Thought Leadership
Insight

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,...
Insight

The Role of Qualitative Interviews in Ensuring a Patient-Centered Approach to Clinical Trials

Author: Morgan Vlad-McCabe Clinical trials play a crucial role in advancing medical research and improving healthcare outcomes. Traditionally, they have primarily focused on objective measures and quantitative data to evaluate the safety and efficacy of treatments. In recent...
Webinar

EU CTR: An Introduction to European Clinical Trial Transparency

Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
White Paper

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...
White Paper

Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling

Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft...
Insight

The Future of eCOA and Wearable Devices

Electronic Clinical Outcome Assessment (eCOA) wearables have been a major player in the collection of large volumes of patient-reported data. With clinical research generating large and complex datasets at a rapid rate, the value of eCOAs is increasingly apparent, offering new...
Insight

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...
Webinar

LifeSci Talks COA Series | Harnessing Implementation Science to Improve Health Outcomes: Methods and Approaches for the Future

Implementation science emerged as a response to the recognition that many effective health interventions and innovations were not being widely adopted or sustained in practice, even when evidence of their efficacy was strong. Join Meredith Smith, Senior Director of Implementation...
Insight

How Medical Writing Can Drive Patient Engagement

Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and...
Webinar

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 &...
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

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...
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

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...