Thought Leadership
3 Ways to Leverage Generative AI in Pharmacovigilance
Discover how clinical and regulatory teams can leverage AI-powered workflows, generative artificial intelligence (GenAI), and machine translation in PV processes and documentation. Learn the top three use cases for AI-powered workflows in PV & safety, including safety intake...
How to Select the Right Regulatory Writing Company for Your Organization's Needs
Discover how clinical and regulatory teams can select the right regulatory writing and consulting company to fit their organization's needs. Learn the top five considerations when selecting the right regulatory writing and consulting company, including expertise and...
5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions
Discover how clinical and regulatory teams can mitigate risk, maintain compliance, reduce administrative timelines, and save on costs by leveraging the transformative power of generative artificial intelligence (GenAI) and machine translation workflows. Learn the five significant...
AI and MT for PV and Safety Office Hours - 6/12/24
Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some...
AI and MT for Regulatory and Clinical Content Office Hours - 5/15/24
Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some...
How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations
In this piece, we'll explore the two primary frameworks that are driving EU CTR transparency efforts: the European Medicines Agency’s Policy 70 and Regulation (EU) No. 536/2014 on clinical trials. Gain valuable insight into requirements, exceptions, and implications for all...
Unlocking the Power of AI and Machine Learning in Life Sciences
Life sciences companies are putting artificial intelligence (AI) and machine learning (ML) into practice, realizing its potential to revolutionize adverse event detection, diagnostics, and more. For AI and ML to be truly effective, you need to give context to your data, teaching...
4 Immediate Applications for AI Translation in Pharma
Precision and speed are key facets of success in the dynamic world of pharmaceutical development. To achieve these goals, AI-powered capabilities, such as machine translation (MT), can have a considerable and transformative impact. Automated translation workstreams enable...
ICH E6(R3): Understanding the Updated Good Clinical Practice Guidelines (GCP) and Their Future Impact
The International Council for Harmonization (ICH) announced revisions to its Good Clinical Practice (GCP) guidelines, marking a significant move towards more closely aligning clinical practice with the rapidly evolving technological and regulatory landscape. What are the key...
LMS: A Must For Study Compliance And Efficiency
Life Sciences organizations function in a heavily regulated global environment, as such, have strict training requirements when it comes to investigative site staff and vendors with involvement in a study protocol. This training is necessary not only to minimize the risk of...
MDR and IVDR Timeline Overview
In order to take advantage of the MDD extension, device manufacturers must comply with several near-term deadlines and plan for long regulatory turnarounds – the extension provides less time than you might think! Learn how TransPerfect can help you meet the impending MDR and IVDR...
Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content
Discover how Health Canada's transition to XML-based templates is reshaping Canadian healthcare content management. Learn about the benefits of XML formats, phases of implementation, and the transformative potential for pharmaceutical companies. TransPerfect Life Sciences...
Transitioning Clinical Trials Under the EU CTR
The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
Navigating the Regulatory Landscape for Expanded Access Programs
Preview: Discover the world of expanded access programs (EAPs) and the dynamic regulatory environment they operate in. In this blog, we delve into the significance of EAPs, the evolving global regulations governing them, and the vital role they play in providing timely treatment...
EU CTR: An Introduction to European Clinical Trial Transparency
Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
EU CTR White Paper - Operational Considerations & Challenges
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU...
IMP Labeling: EU CTR Transition Considerations
The blog post explores the critical aspects of transitioning Investigational Medicinal Product (IMP) labeling from the EU Clinical Trial Directive (EU CTD) to the new EU Clinical Trial Regulation (EU CTR). ...
Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider
Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider...
Driving Digital Excellence: Delivering Seamless and Personalized Customer-Centric Experiences
The digital evolution in reaching and engaging with global communities, including sponsors, CROs, patients, and HCPs, has drastically shifted the way medical affairs teams connect with key stakeholders. As the industry pursues ways to improve a consumer and patient-centric...