Life Sciences

ifeel Selects ��ɫ Life Sciences for Digital Health Translation Initiatives

jpressman — Thu, 31 Oct 2024 14:02:31 +0000

ifeel Selects ��ɫ Life Sciences for Digital Health Translation Initiatives jpressman Thu, 10/31/2024 - 10:02

Press Release

Localization & Voiceover ��ɫ Enable Global Expansion of Workplace Mental Health Resources

NEW YORK, October 31, 2024 – ��ɫ Life Sciences, the leading provider of content solutions and AI technologies to support global clinical trials and product development worldwide, today announced that ifeel has selected its comprehensive localization services in support of its global growth strategy.

Founded in Spain in 2017, ifeel provides services to help companies improve mental health in the workplace. With a team of over 600 licensed therapists that can support clients in 25 languages, ifeel offers comprehensive, reliable, and tailored mental health care to help employees reach their personal and professional goals.

ifeel’s work with ��ɫ Life Sciences began with Italian localization of its app and web experiences for users and therapists. Due to the success of this engagement, ifeel expanded its work with ��ɫ to include media localization, voiceover audio for mental health modules, content workflow guidance, and translation management consulting. ifeel is now working with ��ɫ Life Sciences to widen its reach through German localization, with a roadmap for ongoing expansion into more languages across more technology experiences.

“We wanted to add a new language to our platform in order to provide our users with a better experience and expand our market reach,” said Gabriele Murrone, ifeel’s Co-founder and CPO. “��ɫ took care of the entire process. We were particularly happy with how the team was attentive to our input and feedbacks and went the extra mile to create very high-quality deliverables.”

��ɫ President and Co-CEO Phil Shawe stated, “ifeel’s success in international expansion is a shining example for other companies to follow. We’re honored to be part of the team.”

About ifeel

ifeel is an employee well-being platform that provides a holistic mental health solution for companies around the globe. With the goal of “humanizing growth,” ifeel supports human resources departments in advocating for mental health at work, which in turn prevents burnout and helps boost employee motivation and retain talent. A team of over 600 psychologists is available 24/7 to assist with services ranging from 1:1 therapy sessions to personalized clinical tools. Learn more at https://ifeelonline.com/en/.

About ��ɫ Life Sciences

��ɫ Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, devices, and therapeutics designed to improve and save lives. Our comprehensive solutions include digital health, clinical trial translation, and language services, management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, and call center support. With offices in over 140 cities worldwide, ��ɫ is the ideal partner to simplify your path from lab to launch by driving quality, mitigating compliance risk, and enhancing patient engagement.

For more information, please visit our website at https://lifesciences.transperfect.com/.

By ��ɫ Life Sciences

Life Sciences

Healthy Birth Day, Inc. Selects ��ɫ Life Sciences for Digital Health Translations

kgentile — Tue, 16 Apr 2024 15:42:53 +0000

Healthy Birth Day, Inc. Selects ��ɫ Life Sciences for Digital Health Translations kgentile Tue, 04/16/2024 - 11:42

Press Release

NEW YORK, April 16, 2024 /PRNewswire/ -- ��ɫ Life Sciences, a leading provider of content solutions and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Healthy Birth Day, Inc. has selected its digital health translation technology and services to streamline the organization's translation processes.

Healthy Birth Day is a women-founded nonprofit organization that improves birth outcomes through programming, advocacy, and research. At the forefront of its initiatives is the Count the Kicks stillbirth prevention program, which educates expectant parents across diverse communities on the importance of tracking their babies' movements in the third trimester of pregnancy. Already serving 29 states, the nonprofit required translation support to reach limited English proficient (LEP) expectant families throughout the US.

Healthy Birth Day chose ��ɫ's digital health translation services for the centralized, collaborative workflows and review cycles that help to simplify the localization process for apps, platforms, and websites. With ��ɫ's solution, the Count the Kicks app and materials have been localized into 20+ languages while adhering to state health grant requests, cultivating new connections with diverse populations.

"Health equity is at the center of our work, and we've been searching for a solution that would meet our rapid expansion needs and help us address racial disparities that persist in stillbirth rates across the country," said Christine Tucker, Health Equity Manager at Healthy Birth Day. "With ��ɫ's help, we've been able to reach more families and educate them on the importance of monitoring their babies' movements and advocating for themselves if they notice a change."

��ɫ President and Co-CEO Phil Shawe remarked, "We're proud to support Healthy Birth Day's work and appreciate the trust they've placed in ��ɫ to support their multilingual requirements."

About Healthy Birth Day, Inc.
Healthy Birth Day, Inc. is a 501(c)(3) nonprofit organization dedicated to the prevention of stillbirth through programming, advocacy, and research. Healthy Birth Day, Inc. is the creator of the Count the Kicks stillbirth prevention program, which is credited with lowering the stillbirth rate in Iowa by more than 30% in the first 10 years (2008-2018). The free Count the Kicks app is a powerful stillbirth prevention tool to help expectant parents be more in tune with their bodies and their babies. Learn more at HealthyBirthDay.org and CountTheKicks.org.

About ��ɫ Life Sciences
��ɫ Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 140 cities worldwide, ��ɫ is the ideal partner to simplify your path from lab to launch by driving quality, mitigating compliance risk, and enhancing patient engagement.
For more information, please visit our website at https://lifesciences.transperfect.com/.

��ɫ Life Sciences

Life Sciences

��ɫ Life Sciences Releases Trial Interactive 10.5

jpressman — Tue, 28 Nov 2023 15:28:36 +0000

��ɫ Life Sciences Releases Trial Interactive 10.5 jpressman Tue, 11/28/2023 - 10:28

Press Release

E-Clinical Platform Helps Sponsors with Study Management Automation and Mobility

NEW YORK, Nov. 28, 2023 - ��ɫ Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of version 10.5 of its award-winning Trial Interactive eClinical platform. This new version is a significant update and brings new benefits to sponsors, enabling them to further automate oversight for proactive and predictive trial management.

Trial Interactive's user-friendly document and trial management automation helps pharmaceutical, biotechnology, and CRO companies effectively streamline product development lifecycles. The platform improves speed, quality, and compliance with solutions for identification, site feasibility, study start-up, personnel training, regulated content management, eISF, eTMF management, CTMS, and more. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment.

Trial Interactive 10.5 introduces key enhancements in several areas:

Clinical Trial and TMF Health: Trial dashboards and CTMS automation protect patient safety, enforce protocol adherence, and support real-time TMF health and site visit report completion and documentation with continuous data monitoring and event and milestone triggers.
Study Start-Up and Trial Management: A streamlined study start-up experience provides improved site start-up cycle times, advanced reporting for accessible insights, site-specific contract and budget visibility, streamlined submission packages, and enhanced site communication, reducing start-up costs by 30%.
All-in-One Mobile App: myTI combines the power of eTMF, CTMS, and learning management functionalities into a single, user-friendly app available on iOS and Android. This transforms the way that CRAs manage studies, giving them anytime, anywhere access to site management, document submission, site visit scheduling and documentation completion, and training and learning materials, in their language of choice.

With an extensive track record of ensuring that global study teams operate efficiently through all phases of a clinical trial, Trial Interactive facilitates inspection readiness and helps bring life-changing therapies to patients. As an eClinical platform built by clinical professionals for clinical professionals, Trial Interactive takes a practical approach to innovation and collaboration powered by industry experts.

"This update of Trial Interactive gives sponsors even more real-time oversight, process automation, and ease of use, as well as a feature-rich mobile experience," said Michael Smyth, Division President of ��ɫ Life Sciences ��ɫ. "We shape our development roadmap through collaboration with our client community, and we're grateful for their input and the dedication of our product development team, which has turned user feedback into significant platform improvements."

To schedule a demo of Trial Interactive, email info@trialinteractive.com.

About Trial Interactive

��ɫ’s Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and CTMS with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848, or visit www.trialinteractive.com.

About ��ɫ Life Sciences

��ɫ Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, ��ɫ is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at https://lifesciences.transperfect.com/.

About ��ɫ

��ɫ is the world’s largest provider of language and technology solutions for global business. From offices in more than 100 cities on six continents, ��ɫ offers a full range of services in 200+ languages to clients worldwide. More than 6,000 global organizations employ ��ɫ’s GlobalLink technology to simplify the management of multilingual content. With an unparalleled commitment to quality and client service, ��ɫ is fully ISO 9001 and ISO 17100 certified. ��ɫ has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.

By ��ɫ Life Sciences

Life Sciences

Trial Interactive Wins SaaS Award for Best Content Management Innovation

jpressman — Tue, 24 Oct 2023 14:15:42 +0000

Trial Interactive Wins SaaS Award for Best Content Management Innovation jpressman Tue, 10/24/2023 - 10:15

Press Release

��ɫ Life Sciences’ eClinical Platform Recognized for Impact on Clinical Research Processes

NEW YORK, October 24, 2023 – Trial Interactive, a leading eClinical platform supporting global clinical trials and product development for the biopharmaceutical industry, was selected as the winner in the “Best Content Management Innovation” category for the Saas Awards.

Lead Judge Meenakshi Jindal commented, “��ɫ Life Sciences’ Trial Interactive division has made a significant positive impact in the clinical research industry. With its seamless integration of innovative technology, machine learning, and human-aided support, the platform has revolutionized content management processes. Sponsors have experienced remarkable benefits, including streamlined operations, improved compliance, and reduced risks. The time and cost savings achieved are truly remarkable, enabling sponsors to accelerate timelines and allocate resources more efficiently. Congratulations from everyone at the SaaS Awards!”

Trial Interactive’s machine learning and mobile-enabled eClinical solutions for sponsors deliver powerful automation, decentralized capabilities, and an intuitive user experience. Backed by expert-led services, Trial Interactive ensures organizations of any size can succeed in critical clinical work streams and manage trial complexity.

��ɫ Life Sciences ��ɫ President Michael Smyth stated, “Thank you to the SaaS Awards for this honor. It’s exciting for Trial Interactive and its dedicated product development teams to be recognized for their hard work that helps our life sciences clients achieve their goals.”

 About the SaaS Awards

The SaaS Awards is a sister program to the Cloud Awards, which was founded in 2011. The SaaS Awards focuses on recognizing excellence and innovation in software solutions. Categories range from Best Enterprise-Level SaaS to Best UX or UI Design in a SaaS Product.      

About Trial Interactive

About ��ɫ Life Sciences

By ��ɫ Life Sciences

Life Sciences

Blue Cross Blue Shield Spotlight

kgentile — Fri, 28 Jul 2023 17:40:32 +0000

Blue Cross Blue Shield Spotlight kgentile Fri, 07/28/2023 - 13:40

White Papers

Life Sciences

Overcoming 5 Challenges of Implementing eClinical Technologies

jpressman — Fri, 28 Apr 2023 16:15:22 +0000

Overcoming 5 Challenges of Implementing eClinical Technologies jpressman Fri, 04/28/2023 - 12:15

Blog

eClinical technology has transformed the clinical trial landscape, maximized data collection efficiency, and streamlined trial operations. Innovations in this space, such as electronic trial master files (eTMF), clinical trial management systems (CTMS), and electronic patient-reported outcomes (ePRO), have also contributed to a more cost-effective, holistic, and accurate representation of patient data.

However, many organizations face several challenges that can impede the successful rollout of new technological resources. The main challenges include harmonizing technological initiatives with a team of people trained to manage the system and entering the appropriate data points. Without the human component, a robust clinical tool will continue to fall short of its intended goal and fail to provide valuable insights, impacting optimal clinical management decision-making.

Other factors impeding the successful implementation of clinical technologies include user acceptance, data security, and regulatory compliance. Once these potential setbacks are identified and planned for, teams can adequately prepare to launch new technologies as part of their research initiatives with minimal interference to cost, timelines, and data quality.

Let’s assess five common pitfalls trial teams face when incorporating new technology and identify potential solutions to mitigate the common risks.

#1 Data Input and Quality

One of the key benefits of eClinical technologies is the ability to collect and manage data in real time. This simplifies clinical trial monitoring and identification of potential issues. However, data quality may be jeopardized, especially where data is entered or stored inaccurately.

To ensure high-quality data, it is critical to train staff thoroughly on data input, management, and quality. In conjunction with an eTMF, for example, adequate human intervention is needed to run thorough quality control checks, index documents, and maintain the expected document list (EDL).

As part of a robust initiation, ensure you establish clear guidelines for data entry and maintenance in accordance with quality standards. In addition, it is important to monitor data quality throughout the trial and leverage data clean-up procedures to proactively identify and correct errors before they are compounded further into the trial.

#2 Resistance to Change

One of the most significant challenges of eClinical technologies is the resistance to change from the traditional paper-based systems that have been used in clinical trials for decades. Moving from paper-based systems to electronic ones requires significant changes in how clinical trials are conducted and can be challenging for those who are accustomed to traditional methods.

To prepare and ensure a smooth transition, develop a clear plan for implementing eClinical technologies that includes extensive training and support for clinical research staff. In addition, it is important to involve stakeholders from the beginning of the project to gain buy-in, understand and address preliminary concerns, and build a culture of collaboration and cooperation.

#3 Data Security

Collecting and managing sensitive patient data is a pivotal component of clinical trials, commanding tight security systems to protect it. Data breaches and security lapses may result in reputational damage, regulatory penalties, and even legal action.

To combat these, create robust security measures compliant with relevant regulations and standards, such as the General Data Protection Regulation (GDPR), CFR Part 11, and the Health Insurance Portability and Accountability Act (HIPAA). Furthermore, it is important to train clinical research staff on data security best practices and monitor systems for potential vulnerabilities.

#4 Integration with Existing Systems

Each clinical trial involves multiple stakeholders, including sponsors, contract research organizations (CROs), investigators, and study sites, and each may have different technology systems in place. Successful integration with these systems can be complex and time-consuming, especially where there are compatibility issues and roadblocks.

To mitigate this, it is critical to develop an airtight integration strategy, encompassing the identification of systems requiring integration and any data exchanges. In this stage, it is also important to involve all stakeholders to ensure that the integration can be successfully implemented without the loss of data or creating complications with individual systems.

#5 Regulatory Compliance

With a rapidly evolving regulatory landscape on both a local and global scale, keeping in lockstep with changes to guidelines and requirements can be complex. The use of electronic systems as part of clinical trials is subject to stringent regulatory requirements, including those set out by the FDA and the European Medicines Agency (EMA).

Based on their understanding of the regulatory landscape, clinical research teams should develop a comprehensive regulatory strategy that outlines the regulatory requirements and the steps they will take to ensure compliance. A quality management system (QMS) can also ensure consistency and facilitate visibility into processes to ensure compliance protocols are being adhered to. The QMS should be designed to ensure that the technology is developed, implemented, and used in compliance with regulatory frameworks.

Conclusion

With the introduction of new technologies to a trial, research teams should implement a strong framework to roll out and train staff effectively. Although eClinical technologies offer unique advantages in data collection and streamlined trial monitoring, data quality can be compromised if not managed effectively. Proper training of staff on data input, management, and quality is crucial to maximizing eClinical capabilities. Through continuous monitoring of data quality throughout the trial and implementing data clean-up procedures, these tools can be leveraged to their full potential.

Furthermore, by developing robust security measures alongside an airtight integration strategy and training programs, the risk of delays, poor data quality, security breaches, and compliance issues are significantly reduced. This maximizes technological capabilities to enhance the quality and reliability of the data, ultimately leading to improved patient outcomes and advancing the development of life-saving treatments.

Looking to optimize your clinical technology rollout strategy? ��ɫ Life Sciences is an industry leader in practical, global eClinical innovation, simplifying processes for sponsors, CROs, and sites around the world.

By ��ɫ Life Sciences

Life Sciences

Centralizing Global Content for Patient Engagement Teams

dmarra — Tue, 11 Apr 2023 17:51:56 +0000

Centralizing Global Content for Patient Engagement Teams dmarra Tue, 04/11/2023 - 13:51

Blog

Patient welfare and engagement are central to an effective healthcare system, and engagement teams play a vital role in ensuring that patients receive the best care possible. In fact, a study conducted by the American Journal of Managed Care found that patients who are directly engaged in their healthcare have higher levels of satisfaction with their healthcare experience, improving adherence and health outcomes. This can be ascribed to the fact that these patients often feel more involved in the decision-making process and can contribute to the care they receive.

While it is generally agreed that patient engagement is a critical component of the healthcare system, patient engagement teams also face challenges that may impact their ability to deliver effective patient engagement strategies. As part of a broader patient engagement strategy, centralizing processes and content creation can help to establish consistency, efficiency, and customization for local market needs.

Let's explore these challenges and assess how centralizing global content may play a part in a robust patient engagement strategy.

3 Challenges for Patient Engagement Teams

Lack of Standardization

Decentralization of processes and content creation may cause inconsistencies in communication, data collection, and patient comprehension, making it difficult for teams to measure and analyze engagement efforts effectively. For example, where different teams are operating at different sites with no standardization of content and quality, there may be limited oversight, resulting in potential errors or inaccuracies. These variations in content quality may impact the efficacy of the content, potentially resulting in potentially lost time, resources, and spend.

Inefficiencies Across Sites

Across sites, there may be different teams or departments developing patient engagement content without coordinating these activities with others, potentially resulting in a duplication of efforts. Furthermore, this can make it difficult to measure the efficacy and results of the content on a large scale. Ultimately, this may have an impact on the propensity toward the improvement and optimization of content creation processes.

Data Management

Multiple sites often generate large volumes of patient engagement data, which can be complex to efficiently manage and analyze. Decentralized efforts may result in patient engagement data being collected and stored in multiple systems, leading to data fragmentation and rendering data vulnerable to security breaches. As a result, teams may be unable to harness a holistic view of patient engagement efforts across the organization. This invites the risk of inconsistent data quality, leading to incomplete or inaccurate patient engagement data. This is further compounded by challenges associated with integrating patient data with other healthcare systems and electronic health records. As a result, teams may be disempowered to make fully informed decisions and optimize patient engagement efforts.

3 Benefits of Centralized Global Content for Patient Engagement Teams

Consistency in Messaging

By centralizing global content solutions, patient engagement teams can ensure that their messaging is consistent across all regions and languages. This consistency can help build patient trust, improve patient outcomes, and increase patient satisfaction.

Furthermore, one central repository for content enables full visibility into the creation/development and deployment processes. The development of a standardized quality control process can enforce quality standards across sites, ensuring content is consistent in tone, style, and messaging This is especially critical when developing multilingual content, for all patients to be empowered with consistent information in their language.

Improved Process Efficiencies

Through centralization, teams will be able to better create and manage content at scale, which is particularly beneficial for organizations with multiple locations or large patient populations. In tandem with standardization, teams will be able to assess resource needs and allocate resources appropriately. This can reduce sunk costs associated with inefficient resource management and redirect efforts toward alternate engagement strategies, such as patient education.

Furthermore, teams will be able to establish robust frameworks for collecting and analyzing patient engagement data, helping to provide insights into content reception and performance across different locations and channels. This highlights any areas where improvement and optimization are needed.

Enhanced Data Protection

Consolidating data in a centralized repository can simplify processes in managing and analyzing data generated from content creation, reducing the risk of errors or data inconsistencies.

With standardized data management, patient engagement teams can enforce security through a single point of access. Implementing a robust security framework, which incorporates key compliance protocols such as CFR Part 11 compliance, can reduce the risk of data breaches or unauthorized access to patient engagement data. Through centralization, these security measures can be more effectively implemented and monitored across sites.

This not only ensures airtight protection of sensitive data but also facilitates streamlined data analysis and trend identification. Teams will be able to generate standardized reports, curate dashboards, and generate a comprehensive view of content performance across locations and channels.

Conclusion

Centralization ultimately ensures consistency in messaging while improving process efficiencies and enhanced data security. A successful move to a centralized platform for global content development can empower patient engagement teams to deliver personalized care to a broad scope of patient populations without risking communication gaps and empower patients with the information they need to make informed decisions about their healthcare.

As a language service provider, we understand the importance of patient engagement and are committed to helping patient engagement teams deliver the best possible care to their patients. Our GlobalLink technology empowers teams to centralize their content creation efforts and maximize their resource investments.

By: ��ɫ Life Sciences

Life Sciences

What Are Unitary Patents and What Do They Mean for Life Sciences Companies?

dmarra — Tue, 11 Apr 2023 17:16:59 +0000

What Are Unitary Patents and What Do They Mean for Life Sciences Companies? dmarra Tue, 04/11/2023 - 13:16

Blog

A Unitary Patent (UP) is a new system for patent protection in the EU that aims to simplify the complex and costly validation and translation requirements. The initiative is expected to have a significant impact on life sciences organizations in the EU by reducing costs, simplifying validation procedures, and increasing patent protection across a broader spectrum of countries.

The goal of a Unitary Patent is to simplify the European patent system by reducing complexities and costs in validation and translation requirements in up to 25 EU Member States. In addition, it seeks to protect IP across a broader spectrum of countries by removing cost barriers to international patent protections and providing a Pan-European solution under a single litigation process.

Germany was the last Member State to ratify the agreement on a Unified Patent Court on February 17, 2023. This started the countdown as set under Article 89 of the UPC Agreement, which states the Agreement will enter into practice on June 1, 2023.

Impacts on Life Sciences Patent Protections

Reduced Costs

The implementation of the UP will significantly reduce costs and administration of filing for patent protection, as life sciences innovators were previously forced to navigate complex and costly validation procedures. Currently, national validation costs vary based on specific state requirements and translation stipulations, amounting to thousands in excess of the now predicted annual cost.

Simplified Validation Process

With the UP implementation, all patents are still issued through the European Patent Office (EPO). However, instead of having to select one by one in the online checklist, innovators can select UP, which covers up to 25 Member States. Please keep in mind that non-UP Member States, such as the UK, Spain, Turkey, and other countries not included in the UP, need to be selected as well. The UP will also provide a more streamlined approach to patent litigation, with a single court having jurisdiction over disputes across all Member States.

Translation Requirements

Overall, a UP will present fewer logistical challenges associated with translation. The basic requirements remain, adhering to the three official languages of the EPO—German, French, and English. The application of Rule 71.3 is to remain exactly the same, requiring the submission of a translation of the claims in the two official languages of the EPO, which are different from the language used in the proceedings. This request is included in the communication and must be completed within a non-extendable four-month period.

Once one of these has been fulfilled, there is no requirement for the patentee to translate once the transition period has passed. While there is some efficiency to be gained by fewer translation challenges, this is most noticeable by IP law firms and IP owners' applicants not using a centralized translation provider. There is a significant reduction in the time one has to comply after the EP is granted and the decision is made to go to UP: from three months to one month only. This is an important point to take notice of and ensure processes for decisions and internal approvals are lean.

Conclusion

By streamlining validation and translation procedures and reducing costs, UPs aim to make it easier and more efficient for innovators to obtain patent protection across a broader spectrum of countries.

A UP is expected to significantly reduce costs and administrative burdens generally encountered when obtaining EU patent protections. Furthermore, a simplified validation process and streamlined approach to patent litigation under the UP system will provide a more efficient and effective way for life sciences companies to protect their IPs. This will provide enhanced certainty and predictability for life sciences companies in the process of obtaining patent protections, enabling companies to focus on core business activities and innovations.

Life sciences organizations looking to ensure a well-rounded strategy for UP should engage stakeholders and vendors early in the process, which includes translation vendors and litigation support and consulting. Reach out to ��ɫ Life Sciences, and connect with one of our experts to discover how your organization can best prepare for these changes to IP protections within the EU.

By: ��ɫ Life Sciences

Life Sciences

The Quality Review of Documents (QRD) v9.0 for Veterinarians: A Step Toward Better Care

dmarra — Mon, 20 Mar 2023 19:07:44 +0000

The Quality Review of Documents (QRD) v9.0 for Veterinarians: A Step Toward Better Care dmarra Mon, 03/20/2023 - 15:07

Blog

The Quality Review of Documents (QRD V9) update came into effect on January 28, 2022. The new version consists of a set of guidelines established by the European Medicines Agency (EMA) outlining the responsibilities and duties of those who ensure the quality of veterinary medicines. The update to V9.0 includes several key changes aimed at improving the overall quality of veterinary care and prioritizing animal welfare.

With that said, the effort to convert products to comply can be overwhelming at first when following a traditional track changes/copy-and-paste approach. Partnering with a vendor with the appropriate technology can help to simplify the approach, potentially minimize human intervention, and focus the manual effort on ensuring the highest-quality update.
Ultimately, the best starting point is having a well-rounded understanding of the guidelines, since they can be complex. Identifying a partner who is thoroughly familiar with these regulatory shifts is therefore essential. To start, let’s assess some of the key components of the QRD and then look at preparation for ensuring a seamless transition.

Key Guidelines from the QRD

Quality Management System

The regulation requires the implementation of a quality management system to ensure that veterinary medicines are manufactured and distributed according to the relevant regulations and standards.

Real-World Data

The guideline emphasizes the use of real-world data to support the approval and post-approval monitoring of veterinary medicines. The qualified person (QP) is responsible for evaluating and interpreting real-world data and ensuring that it is properly documented and reported.

Clinical Trials

The QP will be required to oversee the design, conduct, and reporting of clinical trials to ensure that the results are reliable and that the study protocols follow ethical standards.

Batch Release

The QRD V9.0 requires the QP to verify that each batch of veterinary medicine produced complies with the relevant regulations and standards before release. The QP must also ensure that adequate quality controls are in place throughout the manufacturing process.

Document Control

All relevant documents related to the manufacturing and distribution of veterinary medicines are required to be properly controlled and maintained. The QP must ensure that all documents are up-to-date and easily accessible.

Complaints and Adverse Reactions

The QRD V9.0 requires the QP to investigate and resolve any complaints or adverse reactions related to veterinary medicines and to report any significant issues to the relevant regulatory authorities.

How to Prepare for the QRD V9.0: Tips for Success

Understand the Guidelines

The first step in preparing for the QRD V9.0 is to familiarize yourself with the updated guidelines. Read through the guidelines carefully to understand the changes and the expectations of the regulatory authorities.

Assess Your Processes

Once familiar with the guidelines, take a close look at your current processes to determine if they need to be updated. Make changes as necessary to ensure that they align.

Invest in Technology

The QRD V9.0 update places a strong emphasis on the use of technology to improve veterinary care. Consider investing in technology that will help you collect and analyze real-world data, communicate with clients, and manage your patients' medical records.

Invest in Training

To ensure that you are fully prepared for the QRD V9.0 update, seek out training and education opportunities. Attend workshops, conferences, and webinars to learn about the latest developments and to stay up to date on best practices.

Team Collaboration

The QRD V9.0 update impacts all members of your veterinary team, so it's essential to collaborate and work together to ensure a smooth transition. Hold team meetings to discuss the updates, share best practices, and ensure that everyone is on the same page.

Conclusion

The update of the QRD V9.0 is a significant development in the veterinary industry. Assessing your existing processes and aligning to ensure you are adhering to these guidelines prepares you and your team for the changes and ensures that you are providing the highest-quality care for your animals.

��ɫ Life Sciences has established a process enabling affected organizations to update their content in accordance with QRD V9.0 either as part of the process or as a proactive step. As part of this, we also provide regulatory consulting and guidance on the best approach for managing content and ensuring compliance with the guidelines.

Concerned about the volume of content requiring updating? We’ve developed a program that will define everything for you and can help you update all your products with an efficient and cost-effective, custom-built process. If you are curious to learn more, contact ��ɫ Life Sciences today to assess and implement a successful compliance strategy.

By: ��ɫ Life Sciences

Life Sciences

Leveraging Social Media for Patient Recruitment in Clinical Trials

dmarra — Mon, 13 Mar 2023 18:56:42 +0000

Leveraging Social Media for Patient Recruitment in Clinical Trials dmarra Mon, 03/13/2023 - 14:56

Blog

Identifying and connecting with prospective patients for clinical trials via social media and digital channels presents several challenges due to regulations that restrict patient communications. For example, the FDA has issued guidelines on the use of social media in patient recruitment. The guidelines recommend that researchers ensure that the content of their social media posts is accurate, balanced, and not misleading.

The European Medicines Agency (EMA) and the European Commission (EC) enforce strict rules ensuring the safety and efficacy of clinical trials and protecting patient privacy. With social networks, such as Facebook, regularly changing their guidelines for advertisements, it can be challenging to keep up with the ever-shifting environment. Life sciences organizations are continually faced with regulatory complexities and hurdles in connecting with key patient demographics.

Let’s delve deeper into the challenges of recruiting for clinical trials through social media and identify areas where life sciences organizations can continue to reach out to target audiences while remaining compliant with regulatory guidance.

Restrictions to Recruiting Patients for Clinical Trials through Social Media
Several countries within the EU have implemented country-specific restrictions on promoting clinical trials on digital platforms, such as Google and Meta. This limits digital reach to these markets and has the potential to negatively impact trial recruitment for prospective patients who are prevalent on these platforms.

Additionally, there are strict guidelines around the use of language in clinical trial promotion. The EMA and EC have guidelines in place to ensure that language used in clinical trial promotion is not misleading or exaggerated. This can make it difficult for clinical trial sponsors and investigators to effectively communicate the potential benefits of a treatment and recruit patients.

A major challenge is the restriction on the use of patient testimonials in clinical trial promotion. Patient testimonials can be powerful tools for recruiting patients, but they are not allowed under EMA and EC regulations. This means that clinical trial sponsors and investigators are not able to use real-life stories or quotes from patients to promote their trials on social media or online.

Ensure Successful Patient Recruitment through Social Media with These 4 Strategies

To overcome some of these challenges, clinical trial sponsors and investigators can use these four strategies.

#1 SEO
Optimizing website content for specific keywords enables clinical trial sponsors and research organizations to attract more potential participants who are actively searching for information about their conditions or treatment options. This also enables organizations to demonstrate their expertise in a particular area and build trust with potential participants. When targeting global markets, optimizing multilingual sites/pages following local keyword research and SEO best practices is critical to ensure even coverage of the global recruitment efforts. In addition to reaching multilingual audiences with the best messaging, multilingual SEO approaches drive organic, high search rankings and, therefore, increase an organization’s chances of meeting its patient recruitment targets.

#2 Incorporate Social Listening
Engaging with the right expertise to conduct market research in new countries can help life sciences organizations assess their target markets in terms of levels of competition and market trends. Rolling out a social listening strategy can capture general audience sentiment and identify relevant conversations and insights into the concerns, opinions, and experiences of patients, plus the types of treatments, interventions, and outcomes that patients are most interested in. This can then be leveraged to paint a clear picture of potential trial partners and design studies that are more patient-centered.

#3 Use Third-Party Sources
Leverage sources, such as news articles or scientific publications, to promote the trial and its potential benefits. Additionally, researchers may use social media to provide general information about the trial and the disease or condition being studied rather than promoting the trial itself.

#4 Use Generic Language
Use generic language that does not imply specific results or outcomes. Limit or eliminate the incorporation of specific patient testimonials.

Conclusion

Generally, many research organizations run into limitations associated with marketing clinical trials and conducting patient recruitment on social media platforms and digital channels in tightly regulated markets. However, by using a combination of alternative strategies, clinical trial sponsors and investigators can still effectively promote their trials and reach potential patients.

Partnering with a vendor with expertise in overcoming these challenges can provide a stronger framework for recruiting and engaging prospective trial partners while remaining in compliance with regulatory requirements.

Curious to learn more? Contact us today to discover how ��ɫ Life Sciences can support your global social media patient recruitment strategies.

By: ��ɫ Life Sciences

Life Sciences