Thought Leadership

Webinar Clinical Research eClinicalTech

The Journey to TMF Rescue: A Case Study in Quality and Compliance

| Step into the world of Trial Master File management with this engaging and informative session, The Journey to TMF Rescue: A Case Study in Quality and Compliance. This webinar unpacks how critical TMF deficiencies were identified and successfully resolved through a methodical and...

Webinar Clinical Research eClinicalPatient Engagement

The Future of Patient Recruitment: AI Trends and Technologies for 2025

| As artificial intelligence continues to change the way pharma companies engage with patients globally, a critical question emerges: how do we ensure patients remain at the heart of clinical research?In our upcoming webinar with Innovative Trials, SOGLIA, SubjectWell, and Pleco...

Top 10 Prompts to Ask ChatGPT for Optimizing Clinical Trial Recruitment Strategies

Clinical trial recruitment is a complex process that requires strategic planning and data-driven decision-making. Use these AI-powered prompts to refine your approach and enhance participant engagement....

Event Clinical Research eClinicalTech

Trial Interactive Customer Summit, OpTImize

- | Join us for the OpTImize Summit, Trial Interactive’s exclusive annual customer event. This invitation-only conference features networking opportunities, product showcases, inspiring client success stories, and thought-provoking sessions led by Trial Interactive experts and...

Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology

Introduction The question of leveraging digital technologies in rare disease studies with smaller patient cohorts is not one of ROI, but rather data integrity. When compared with traditional paper-based patient reported outcomes (PROs), data integrity is much more easily...

Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management

Introduction: In the field of clinical research, a robust data management process is essential for driving success. Efficiently handling vast amounts of data, ensuring accuracy and consistency, and extracting meaningful insights are vital, particularly in the case of global...

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...

The C3 Summit: Boston Recap

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world...

A Conversation with Dr. Elin Haf Davies of Aparito

The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder &...

The C3 Summit: San Francisco Recap

April 20 marked the first in our series of C3 Summits, which kicked off in San Francisco. Throughout the event, we invited industry experts to panel discussions to explore patient diversity, centricity, clinical technologies, and innovations. In this recap, we will...

Overcoming 5 Challenges of Implementing eClinical Technologies

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...

3 Benefits of Centralizing Global Content Solutions for Regulatory Teams

The regulatory landscape is continually evolving, prompting pharmaceutical companies to adjust their strategies to remain in compliance with existing requirements. Since the remote shift throughout the COVID-19 pandemic, regulatory teams have been gradually embracing digitization...

Decentralized Clinical Trials | TransPerfect Life Sciences

This is the second of a two-part series on our recent C3 Summits TransPerfect Life Sciences held C3 Summits in Princeton, NJ; Raleigh, NC; and London, England, where multiple subject matter experts came together to discuss clinical content. Throughout these events, we focused on...

Plain Language Summary Requirements for Clinical Trials

Plain language summaries (PLS) of Clinical Trial Results are a critical tool in medical communication to help disseminate summarized, easy-to-digest research information to general audiences. Typically, these are used to share details of clinical study protocols, publications, or...

Sanofi - The Clinical Translation Centralization Journey in Light of the EUCTR 536/2014

Sanofi centralizes clinical trial translations through GlobalLink and best-in-class AI, MT, and more. ...

5 Ways to Increase Diversity in Medical Product Development

Over the past decade, there has been a critical push for more inclusive clinical trials. Many regulatory bodies, including the US Food and Drug Administration (FDA), require clinical trial data to ensure a medical product’s safety and efficacy prior to approving new treatments....

How TMF Study Owners Can Provide Better TMF Management

Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline. This ensures a TMF is completely up-to-date, compliant, and ready for inspection at a moment’s notice. You know that maintaining high TMF quality is...

Preparing Compliant eCTD Submissions in Asia

In May 2015, the US FDA published final and binding guidance requiring submission within 24 months of certain Common Technical Documents (CTDs) in an electronic format. This was ratified in 2017 and subsequently revised in February 2020 (Rev. 7). Currently, other notifying bodies...

Preparing and Publishing a Scientific Manuscript

If you’re preparing to write a scientific report for a peer-reviewed journal, it’s critical to have a detailed plan before beginning the first draft of your manuscript. Following the correct format and general guidance for manuscript writing is a good start, but there...

How to Choose and Implement a CTMS

The clinical development landscape is awash in technologies that automate everything from subject randomization (IVR/IWR) and subject study assessments and outcomes (EDC, ePRO) to trial master file (TMF) solutions.If you are like many emerging small to mid-sized biotech and...

How to Increase Your Likelihood of Scientific Publication

Writing a scientific manuscript involves considerable planning and organization to boost your chances of publication in a peer-reviewed journal. Here, we show you how to develop a thorough plan to present research logically and how to avoid the common pitfalls of authorship, so...

Driving Fundamentals: Ensuring an Efficient Clinical Research Process

My daughter is learning how to drive. In the U.S., driving a car is almost part of our DNA. For most of us, we learn to drive in our late teens and then continue to drive for the majority of the rest of our lives. At some point, we sort of forget we had to learn how to do it. As...

What Is A TMF Certified Copy?

Legendary designer Coco Chanel famously said about fashion, “If you want to be original, be ready to be copied.”When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors...

Say “Yes!” to Mobile-First CTMS

A lot can happen in 25 years. In that time, we went from landline internet and bulky personal computers to ever-connected mobile devices. In that same time, nearly all global businesses adopted Microsoft Office for numerous daily tasks. Word, PowerPoint, Outlook, and of course...