Thought Leadership

Webinar Clinical Research Regulatory

Mastering Inspector Access: Streamlining Regulatory Reviews

| Regulatory inspections can be complex and demanding, but a well-prepared Trial Master File (TMF) can significantly ease the process. Ensuring seamless inspector access, optimizing TMF quality review workflows, and maintaining compliance with regulatory expectations are critical...

Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation

The global adoption of digital health solutions has revolutionized healthcare delivery, offering unprecedented opportunities for innovation in patient care, diagnostics, and disease management. However, the generation of robust clinical evidence to support these technologies...

AI and MT for Regulatory and Clinical Content Office Hours - 10/9/24

TransPerfect's experts gather to answer questions from global pharma, biotech, and medical device leaders regarding AI and MT use cases, challenges, opportunities, best practices, and more....

Where to Apply Machine Translation in Life Sciences Content Workstreams Right Now

In the life sciences industry, it’s increasingly essential to reduce cycle times and enhance operational efficiencies, especially across clinical and commercial team processes. To address evolving regulations from global health authorities and the common pain points of costs,...

The Imperative of Accurate Translations in Clinical Research

With the increase of global clinical trials, clinical documentation is required to be accurately translated at every stage from lab to launch. Despite the administrative burdens and tight regulatory timelines that clinical teams face, accuracy cannot be sacrificed in life science...

How Pharmacovigilance Automation Solutions Can Help You Meet Tight Regulatory Reporting Timelines

Pharmacovigilance (PV) teams play a critical role in detecting, assessing, understanding, and preventing the unintended adverse effects of medications and treatments. Their work, which includes drug reaction monitoring, drug safety surveillance, side effect monitoring,...

How to Improve the Speed and Accuracy of Patient Communications in Clinical Development

According to Phesi, more than a quarter of clinical trials conducted in 2023 were canceled during Phase II.  As clinical research teams struggle with patient recruitment and engagement under tight deadlines and immense regulatory pressure, patients also grapple with...

Implications of AI in Healthcare and Life Sciences: Ethical Considerations in the Age of AI

Artificial intelligence (AI) models have already shown transformative potential in the life sciences industry, including automating administrative clinical research tasks, analyzing patient data to predict future health risks, synthesizing medical information, and more. ...

Pragmatic Use Cases for AI in Pharmacovigilance and Safety

The rapid rise of artificial intelligence presents an opportunity for effective and transformative applications in pharmacovigilance. Intake, query routing and response, case reporting, HAQs, and more are now extremely feasible use cases that create exponential efficiency in...

3 Ways to Leverage Generative AI in Pharmacovigilance

Despite the rigorous drug safety and efficacy standards in trials, study medicines can have unintended side effects on patients throughout the clinical trial journey and even in the post-market setting. To ensure patient safety and mitigate risk, global health regulatory...

How to Select the Right Regulatory Writing Company for Your Organization's Needs

In a landscape defined by ever-evolving global guidelines from health authorities, many life sciences organizations’ clinical and regulatory teams face challenges in navigating the regulatory affairs writing and document submission process. Adhering to strict rules while...

5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions

Moving a drug from development, through clinical trials, to eventually the market involves many critical content pieces and challenges along the way.   According to research commissioned by Genpact, 72% of senior executives across the life sciences industry cited regulatory...

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...

Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from ...

How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations

Authored by Pierre-Frédéric Omnes, Executive Director The publication of clinical data has been a focus of public policies and regulations in the European Union (EU) in recent years to avoid duplication of clinical trials, foster innovation, and encourage the development of new...

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 landscape.   The purpose of the ICH...

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...

Medical Device Regulation: Less Time Than You Think?

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

In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and...

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

Introduction: Expanded access programs (EAPs) provide pathways to treatment options prior to local marketing authorization in cases where traditional clinical trial participation is not feasible. Usually, these treatments involve investigational therapies (i.e., drugs, biologics,...