Thought Leadership
Insight

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...
Client Story

Interpreters Support Novartis Patient Engagement Team

TransPerfect interpreters and translation services support patient interviews to increase awareness of IRDs. ...
Webinar

Enabling Diversity & Inclusion in Clinical Trials: A CRO & IRB Perspective

Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people—and everyone in the industry is a key stakeholder. Clinical trials today still lack ethnic diversity, and to make trials more inclusive and improve...
Insight

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...
Event

Enabling Patient-Centric Experience Using Connected Data Hub and Wearable Technologies

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Enabling Diversity and Inclusion in Clinical Trials: A CRO & IRB PERSPECTIVE

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Insight

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...
White Paper

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...
Client Story

UMotif - Empowering Patients to Drive Engagement and Adherence

Watch this presentation on how empowering patients with cloud solutions increases engagement. ...
Client Story

TransPerfect’s GlobalLink Helps Top-10 Pharma Meet their EC Deadlines in More than 20 Countries

A top 10 pharma company was facing delays in EC submission deadlines for their global studies....
White Paper

Lessons Learned in the Rush for a Vaccine and the Effects on Language Translation: Creating and Adapting Technologies

The rush to a vaccine has accelerated an already dynamic research process. This has led to many innovations and an evolution of procedures. The language translation industry has seen enormous stressors and has had to create and modify processes and technologies similarly. The...
Insight

How Life Sciences Companies Can Detect Adverse Events on Social Media

Pharmaceutical companies have historically relied on email correspondences, company websites, and physician hotlines as adverse event reporting channels. However, the incredibly high usage of social media means it is no longer a channel that can be ignored. Although safety...
Insight

The Summary of Safety and Clinical Performance (SSCP) for Healthcare Professionals and Patients

In 2017, the European Parliament and the Council of the European Union (EU) set a regulatory upgrade on medical devices to strengthen governance structure. This regulation update includes increased oversight of notified bodies, new requirements for transparency and traceability,...
White Paper

ISPOR Europe 2020 Virtual Poster - Usability Testing for eCOAs

In order to ensure a fluid experience for a patient, usability testing is a critical data point to consider. Addressing both a patient’s needs and access to a digital platform is key to data collection. TransPerfect, along with our partners from Parexel, Clinical Ink, and...
Insight

5 Common eCOA Migration Issues

With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages, leading...
Client Story

AI Technology Speeds Safety Case Routing

TransPerfect enables a top-10 Pharma company to reduce time to route safety cases....
Client Story

Medical Annotation: Using Natural Language Processing for Adverse Events

TransPerfect's DataForce Streamlines Adverse Event Detection with NLP. ...
Insight

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...
Insight

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...
Insight

Practical Applications of Machine Learning for Clinical Trials

In this blog, you’ll learn more about the business cases for machine learning that offer a clearer path to inspection readiness, as well as greater efficiency, timeliness, and quality in the TMF. You’ll understand the challenges that can be solved by applying machine learning to...
White Paper

The Paper Chase - Clinical Outcome Assessments in the Digital Age

Patients are, at last, gaining a voice in healthcare. Stakeholders have come to recognize that patients have valuable information to share about their experiences with diseases and medications that should influence policy and treatment decisions. The U.S. Food & Drug...
Insight

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...
Insight

Clinical Research 2020: A Trial Interactive Reflection on Resilience and Community

To put it mildly, 2020 has been a time of adjustment. We were taken out of our comfort zones, professionally and personally, and we had to find productive ways to live in the COVID-19 pandemic present. In short, this crisis changed all of our plans, putting many trials on hold or...
Webinar

Content Solutions for MDR & IVDR Readiness

The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical...