Thought Leadership
Webinar

LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site...
Insight

Walking the Tightrope: Navigating Patient Centricity and Burden in Modern Clinical Trials

Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers, and...
Checklist

Digitizing Multilingual COAs: A Practical Guide

Download our guide to ensuring seamless digitization of your multilingual COAs. ...
Insight

Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content

In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and...
Insight

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...
Webinar

Transitioning Clinical Trials Under the EU CTR

The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
Insight

Driving Success in Omnichannel Content Strategies for Global and Local Markets

Introduction:   In the rapidly evolving landscape of life sciences marketing, implementing an effective omnichannel strategy is crucial to driving positive customer experiences and increasing engagement. By seamlessly integrating multiple channels and considering the...
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,...
Event

Beyond Borders: Navigating the Complexities of Omnichannel Content Strategy for Global and Local Markets

Hosted by Christine Buggle, Senior Director at TransPerfect Life Sciences, in discussion with Ewelina Knigawka, Executive Director of Content and Partnership Excellence at Novartis, and Scott Dille, Digital Content Lead at Novo Nordisk, this session outlined key considerations...
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)...
Checklist

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

Patient recruitment and engagement are critical to the success of clinical trials. Yet despite the tremendous progress made in drug development, recruitment and retention remain major challenges. Over the last 25 years, the industry has attempted to crack the code; however, 86%...
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 &...
Webinar

Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities

As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU...
Webinar

How to Maximise Value and Avoid Failure During Life Sciences Dealmaking

Please complete the form below to access the on-demand recording of our webinar. A fantastic expert panel of life sciences dealmaking veterans from AstraZeneca and Merck, with 100 years' collective experience, share their insights on key dealmaking strategies, best practices...
Insight

Centralizing Global Content Solutions for Medical Affairs

With a rapidly evolving landscape and the introduction of new technologies and emerging therapeutics, medical affairs professionals are tasked with remaining in lockstep with the latest industry developments. From a content perspective, this means not only maintaining clear lines...
Webinar

Automation for MDR & IVDR: A Three-Part Seminar - Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements

Part 3: EnCompass Step by Step: A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements...
Webinar

Automation for MDR & IVDR: A Three-Part Seminar - Part 2: Structured Content and CCMS Technology to meet MDR & IVDR requirements: Takeda Medical Device Group, Qserve, & TransPerfect Medical Device Solutions

Part 2: What is a CCMS and How Does It Address the Challenges Posed by MDR and IVDR?...