Thought Leadership

Hearing the Patient Voice Through Technology and eCOA

The intrinsic value of the patient’s voice has been heard. Over the past few years, Notifying Bodies have been ‘vocal’ on their desire for Studies to be more patient centric and diverse. Clinical Outcomes Assessments (COAs), a scientific instrument/measure whose primary function...

7 Considerations for Improving the App Localization Process

App localization can be a complex process, especially for life sciences organizations. With many apps designed with patient experience in mind, such as patient portals designed for the collection of health data and tracking patient journeys, it's critical that...

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...

Considerations and Opportunities in Capturing Oncology Patients’ PRO Data

There has been a historic lack of guidance in capturing patient data for oncology patients. Join Bill Byrom, VP and eCOA Scientist at Signant Health in conversation with Mark Wade, Global Practice Leader at TransPerfect, as they discuss: - The need for specificity of...

Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider

The EU Clinical Trials Regulation (EU CTR) became live on January 31, 2022. The first-year transition period ends on January 30, 2023, so from January 31, 2023, onward, EU CTR is mandatory for any initial submission of interventional clinical trials with investigational medicinal...

Investigational Medicinal Products: Labeling Changes and Their Implications

This information has been updated based on a previous blog we published in 2021.   In May 2014, European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed, replacing EU Directive No. 2001/20/EC to enhance clinical trial safety, efficiency,...

3 Automation Outcomes for Pharmacovigilance and Safety Teams

With the continued implementation of artificial intelligence (AI) and automated systems into the clinical process, automated data management systems have helped to alleviate manual burdens on safety teams to focus on more critical tasks. The goal at present is to enhance data...

Considerations for Improving the Pediatric Experience

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 &...

Building a Successful Partnership: Meeting Sponsor Expectations

To improve clinical trial electronic system development, strong partnerships must be built and maintained between key stakeholders to establish centralized consensus and alignment for high-quality electronic data capture. Join Aaron McCormick, Associate Director, eCOA...

Benefits of Electronic Labels: Investigational Medicinal Products

When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, a label must be on its packaging that provides relevant and important information, regardless of the country in which it is developed. Types of information include...

Plain Language Summaries Checklist

Download your copy of our Plain Language Summaries Checklist....

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...

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...

Veeva Vault & Translation Management System (TMS) Integration

As pharmaceutical companies implement one or more Veeva Vault applications, it is important to consider the global aspect of content. Download our simple checklist to see if your organization could benefit from a connector between Veeva Vault and a TMS....

Lack of Diversity in Clinical Trials: A Conversation

Conversations on Clinical Content (C3) Summit Debrief: Diversity in Clinical Trials This is the first of a two-part series on our recent C3 Summits During the 2022 C3 Summits held in Princeton, NJ; Raleigh, NC; and London, England; TransPerfect Life Sciences was delighted to...

A Checklist for eCOA Solution Deployment: Best Practices and Considerations

Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the...

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...

Reaching Diverse Patient Populations to Drive Inclusivity in Trials

The COVID-19 pandemic was catalytic in highlighting gaps in health outcomes across the globe, with global health inequity disproportionately impacting minorities and communities of color.With a litany of factors influencing individual patient outcomes and access to healthcare,...

Top 10 Biotechnology Company Captures and Disseminates Insights from a Key Advisory Board Meeting

The company enlisted the support of TransPerfect to provide a medical writer with expertise in the genetic disease to transcribe the meeting in full and produce an executive summary detailing the main takeaways and discussions....

Intellectual Property (IP) Strategies to Consider for Life Sciences Start-Ups

Intellectual property (IP) is one of the most valuable assets a life sciences innovator or start-up has. While these companies are often built on the foundations of successful pre-clinical studies, they face a substantial amount of time between obtaining regulatory approvals and...

Clinical Data Services Company Launches its Statistical Webinar Series

“Another great seminar in a long line of excellence. I can only say, keep it up!”...

Connecting with Diverse Patients: How Call Centers Can Improve Patient Recruitment and Retention

Do you recruit patients for clinical trials? If the answer is yes, then how do you reach potential participants? Through emails? Ads on the radio? Do you call someone and see if they are interested? There are many different ways patients are recruited for clinical trials: in...

Electronic Product Information – Everything You Need to Know

One of the latest initiatives being spearheaded by EMA is publishing ePI, or electronic product information. In some respects, the pharma industry has lagged behind other major industries in terms of how documentation and critical information is relayed to the end patient. Due to...

3 Benefits of Centralizing Global Content for eCOA Migration

In recent years, life sciences organizations have been looking for a standardized approach to collecting global patient data while maintaining compliance and adhering to study timeline milestones. For clinical trials launched across multiple regions, time zones, and patient...