Clinical Leader

The top online platform designed to enhance clinical research by linking trial sponsors with innovative service providers. categories

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Continuing Your Research Mission -- Even As Budgets Tighten

4 days ago | clinicalleader.com | Mark Epstein

By Mark EpsteinAmid growing uncertainty in clinical research funding, including proposed budget cuts from the National Institutes of Health (NIH) that threaten indirect support for essential infrastructure, OpenClinica remains a steadfast partner to researchers. These financial constraints place added pressure on clinical trial operations, particularly in areas like staffing, lab space, and technology.
What Is Electronic Data Capture And How Does It Simplify Data Management To Accelerate Success?

1 week ago | clinicalleader.com | Laura Acosta

By Laura Acosta, VP of Product Management, eClinical DivisionElectronic Data Capture (EDC) systems play a pivotal role in enhancing the efficiency of data collection, management, and analysis in clinical trials. By digitizing case report forms and enabling remote access via Software-as-a-Service (SaaS) models, EDC minimizes manual entry errors and ensures data quality through customizable electronic case report forms (eCRFs) with built-in validation.
The Transformative Impact Of EDC Systems

1 week ago | clinicalleader.com | Laura Acosta

By Laura Acosta, VP of Product Management, eClinical DivisionThis article examines the transformative role of Electronic Data Capture (EDC) systems in decentralized clinical trials (DCTs), emphasizing their impact on patient engagement and data integrity. Traditional clinical trial methodologies often suffer from inefficiencies and inaccuracies in data collection.
EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval

1 week ago | clinicalleader.com | Tim Sandle

By Tim Sandle, Ph.D.Biosimilar medicines are becoming more sought after as a way to tackle rising healthcare costs, especially for relatively expensive biologics (as such anti-cancer treatments). 1 This process began in Europe in 2006 with the approval of Omnitrope (somatropin). This paved the way for non-innovator versions of biologicals (as biosimilars) to enter the market once patents expire or when pharmaceutical companies agree to a partnership following regulatory approval.
The Evolving Landscape Of Data Integrity In Good Clinical Practice

2 weeks ago | clinicalleader.com | Andy O'Connor

By Andy O'Connor, ERA SciencesIn recent years, regulatory agencies have placed renewed emphasis on data integrity in clinical trials, bringing clinical practice and data management more closely in line with the well-established expectations seen in manufacturing environments.
A Game-Changer For Oncology Trials

2 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderWhen the FDA clarified that local healthcare professionals (HCPs) involved in DCTs do not need to be listed on Form FDA 1572 (as long as they only perform standard-of-care procedures and are not engaged in research), it initially raised concerns within the clinical research community. The American Society of Clinical Oncology (ASCO) was among the organizations that voiced early apprehension.
Big Benefits, Bigger Burdens?

4 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderThere's been no shortage of opinions around the FDA's DCT guidance, especially when it comes to the integration of local healthcare providers (HCPs). This use of local HCPs in DCTs has been described by some people as a transformative opportunity, but one that comes with complex operational challenges. So, I thought I'd take a closer look into the details of this topic and the common concerns. Why Are We Talking About HCPs & DCTs?
7 Steps To Manage Local HCPs In A Decentralized Trial

4 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderIn my article Local HCPs in DCTs: Big Benefits, Bigger Burdens?, I mentioned the need to implement a centralized system to verify the credentials, licenses, and professional standing of all local healthcare professionals (HCPs) participating in a DCT. There's no right or wrong way to do this, but I did want to follow up and give you this multi-step process that you could use as a template and customize as needed. 1.
Data Overload Determining Which Trial Data To Collect

1 month ago | clinicalleader.com

Clinical trials collect a substantial amount of participant data, but not all of it is necessary. Learn how to decide what data's needed and...
The Evolution Of A Clinical Research Coordinator

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderLike many people in this industry, Briana White admits that her career in clinical research was more accidental than planned. "I first heard about clinical research from an advisor while working on my undergraduate degree," she explains. "At the time, I didn't think much about it because my plan was to go onto med school. Eventually I decided against med school, but I still wanted to stay in the healthcare field.