Thought Leadership
Webinar

Automation for MDR and IVDR: A Three-Part Seminar - Part 1: What Is a CCMS and How Does It Address the Challenges Posed by MDR and IVDR?

Part 1: What is a CCMS and How Does It Address the Challenges Posed by MDR and IVDR?...
Event Clinical Research C3

C3 Summit Princeton

| Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of...
Event Clinical Research C3

C3 Summit London

| Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of...
Event Clinical Research C3

C3 Summit Boston

| Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of...
Insight

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...
Insight

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...
Client Story

Panel: Deploying AI for Translation - Real Life Examples

Learn how leading companies deploy machine translation and the results they are seeing from their MT strategy. ...
Insight

Centralizing Global Content Solutions for Patient Engagement Teams

Patient welfare and engagement are central to an effective healthcare system, and engagement teams play a vital role in ensuring that patients receive the best care possible. In fact, a study conducted by the American Journal of Managed Care found that patients who are directly...
Insight

What Are Unitary Patents and What Do They Mean for Life Sciences Companies?

A Unitary Patent (UP) is a new system for patent protection in the EU that aims to simplify the complex and costly validation and translation requirements. The initiative is expected to have a significant impact on life sciences organizations in the EU by reducing costs,...
Insight

The Quality Review of Documents (QRD) v9.0 for Veterinarians: A Step Toward Better Care

The Quality Review of Documents (QRD V9) update came into effect on January 28, 2022. The new version consists of a set of guidelines established by the European Medicines Agency (EMA) outlining the responsibilities and duties of those who ensure the quality of veterinary...
Insight

Leveraging Social Media for Patient Recruitment in Clinical Trials

Identifying and connecting with prospective patients for clinical trials via social media and digital channels presents several challenges due to regulations that restrict patient communications. For example, the FDA has issued guidelines on the use of social media in patient...
Insight

International Women's Day: Embracing Equity in Life Sciences

International Women's Day is celebrated annually on March 8 to recognize the social, economic, cultural, and political achievements of women worldwide. The theme for International Women's Day 2023 is "Embrace Equity." Promoting gender equity across life sciences is essential to...
Event Clinical Research C3

C3 Summit San Francisco

| Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of...
Insight

IMP Labeling: EU CTR Transition Considerations

The European Union Clinical Trial Regulation (EU CTR) went live on January 31, 2022. The first-year transition period ended on January 30, 2023, so using the Clinical Trial Information System (CTIS) is now mandatory for all initial submissions of interventional clinical trials...
Insight

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...
White Paper

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...
Insight

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...
Webinar

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...
Insight

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...
Insight

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,...
Insight

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...
Webinar

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 &...
Webinar

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...
Insight

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...