Authors


Marthe Masschelein

Latest:

The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research

Simultaneous and niche skills sought amid evolution in clinical data management.


Sarah Hamirani

Latest:

Combating the ‘Talent Wars’ in Biopharma

Competency-based and other creative approaches are needed to address the battle for talent in the clinical research workforce.


Exostar

Latest:

Winning the Competition for Clinical Sites By Reducing Site User Burden

With the number of clinical trials and sponsors increasing every year, meeting enrollment requirements and timelines becomes harder and harder. Please join Almac Clinical Technologies and Exostar as they discuss solutions to attract and retain the right resources to meet your requirements and timelines. Live: Thursday, Aug. 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 27, 2021.


PCM Trials

Latest:

Reducing Patient Dropout Rates and Accelerating Trial Completion

Jon Ernst (Vice President, In-Home Solutions, Decentralized Clinical Trials) discusses today's clinical trial landscape.


Slope

Latest:

The impact an eClinical Supply Chain Management platform can have on your next clinical trial

Sponsors and CROs have historically been responsible for ensuring full chain of custody for their own clinical supply even though the clinical supply is typically outside of their control. It is the burden of the Sponsors and CROs to determine the most efficient way to do that. An eClinical Supply Chain Management platform provides Sponsors and CROs with the assurance that they are meeting their regulatory requirement of full chain of custody and more importantly ensures that all needed clinical supplies are available and all samples get where and when they are needed.


Debbie Gilmore

Latest:

Harmonizing Outsourcing to Keep Clinical Trials on Track

A shared partnership culture is critical in navigating today’s complex terrain.


Caroline Redeker and Cheryle Evans

Latest:

Navigating the Future of Decentralized Clinical Trials

Although executive enthusiasm for decentralization of clinical trials has grown significantly, operationalizing these models requires meticulous planning and risk-based quality management.


Michael K. O’Brien, PhD

Latest:

A Market Failure for Antimicrobial Resistant Medicines

While the world focuses on COVID-19, this article provides insight on the current state of the market for antimicrobial resistant (AMR) medicines.


Varun Mishra, BAMS; Subhashree Behera, PharmD; Chirag Shah, PhD

Latest:

Challenges in Conducting Multicentric Infectious Giardia Diarrhea Clinical Studies in India

Multicentric studies on diarrhea are essential for comprehending its epidemiology, causes, and treatment outcomes.


Dave Li, MD, PhD

Latest:

Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial Planning

Successful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.


Sirj Goswami, PhD

Latest:

Understanding Project Optimus

Why oncology needs dosing redesign.


Todd Georgieff, BPharm, MBA

Latest:

Clinical Trial Matching Solutions: Understanding the Landscape

A framework to understand the different approaches of trial matching solutions and the major operational and workflow challenges that all matching solutions share.


Davy James

Latest:

Muvalaplin Found to Significantly Lower Lipoprotein(a) Levels, Offering Hope for Cardiovascular Disease Patients

The Phase II KRAKEN trial demonstrated that muvalaplin, Eli Lilly's first-in-class oral small molecule inhibitor, significantly reduces lipoprotein(a) levels with minimal adverse effects, offering a promising new approach to addressing a major cardiovascular risk factor.


Maria Florez

Latest:

Workforce Trends in Drug Development

Tufts CSDD study breaks down state of the talent pipeline from lens of senior leaders.


Mavys Palacios

Latest:

De-Risking Trials with Science-Driven Oversight

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.


Devry Spreitzer

Latest:

When Should the Audit Trail Begin?

A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.



Sailesh K. Patel

Latest:

R&D Using the Metaverse and Digital Twins

How the digital environment can transform drug development space.


PurpleLab

Latest:

PurpleLab Accelerates Clinical Trial Lifecycle with Real-World-Data

Jason Gagner (Vice President of Product for Life Science, PurpleLab) talks about clinical trial variables and how PurpleLab is working to maintain patient retention and accelerate site feasibility.


Sarah Kosta, PhD

Latest:

Enhancing Empowerment in Patient-Focused Research

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.


Julia Oddy

Latest:

Tailored Patient Involvement in Clinical Trials

The approach of the Cancer Research UK Centre for Drug Development.


Christine Moore, PhD

Latest:

Why and How to Infuse Methodological Rigor into Psychedelic Clinical Trials

Renewed interest in psychedelic research shows great promise for patients in need of more effective therapies.


Mary Jo Lamberti, PhD; Abigail Dirks, MS; Nicholas Kikuchi; Neha Patel Cervantes; Ken Getz, MBA

Latest:

An Examination of the Use of Patient Recruitment and Retention Tactics for Global Studies

In light of scant published data from sponsors and contract research organizations on site activation and recruitment challenges following the COVID-19 pandemic, the primary objective of this research is to revisit the results of recruitment and retention tactics in studies conducted in 2012 and 2019.


Mignon Loh, MD

Latest:

Patient-Tested Practices for In-Home Trials

Bringing clinical trials to patients’ homes can address existing site-based challenges.


Ingrid Oakley-Girvan, PhD

Latest:

The Powerful Impact of Caregivers on Clinical Trials

Considering caregiver-supported trials to improve patient retention and outcomes.


Jennifer Kamara

Latest:

How Clinical Trial Research Sites Can Gain Access to a More Level Playing Field

To overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.


Dan Beaudry

Latest:

The Eradication of False Signals in Monitoring

How optimizing RBQM risk detection reduces the efforts caused by false signals.


Heidi Nai Soraya Roslan

Latest:

Managing Clinical Trial Agreements

How Clinical Research Malaysia sped up CTA turnaround using a web-based system.


Bruce Miller

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.


Bhavish Lekh and Ola Gudmundsen

Latest:

Industry Perspectives on the Key Challenges in Trial Optimization

For advancement, pharma must focus on streamlining clinical operations.

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