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Peer-Reviewed Articles

Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation

By Mary Jo Lamberti, PhD, Ranjana Chakravarthy, Kenneth A. Getz

Study finds that despite the use of new approaches to streamline and accelerate study start and improve site selection and activation, the impact on start-up cycle times has been limited. The reasons why are explored.

Exploring the Role of the Regional Coordinator

By Therese S. Geraci, Lillian Carroll, Connie Kingry, Janice M. Johnson, SMC, Debra Egan, Jeffrey L Probstfield, MD, Sara M. Pressel, Linda B. Piller, MD

The largest antihypertensive trial ever conducted throughout North America, ALLHAT, was organized using a coordinating center model for oversight. Regional coordinators played a key role in carrying this trial out.

Are Phase III Clinical Trials Really Consistently Behind Schedule?

By Harold E. Glass, PhD, Lucas Miller Glass, Jesse M.Glass, Phuong Tran

With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.

FDA Inspections

According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. Any deviations during an inspection can lead to a Form 483, leading to a lengthy process to address the problem.
 

These articles can help you prevent receiving a 483 by creating best practices.
 

Read more.

Data Analysis

Best Practices in Patient Recruitment

This Best Practice in Patient Recruitment report displays what percentages of patients are recruited from and where.

Late Phase Study Trends and Market Outlook

This recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.

Phase II-III Market Dynamics

Report shines light on the current state of the Phase II/III clinical trial market and its anticipated direction into 2020.

ACT TV

Events

World Drug Safety Congress Europe 2016

September 14 - 15, 2016
Maritim Hotel, Munich, Germany

Lay Summaries Summit 2016

September 19 - 20, 2016
Philadelphia, Pennsylvania

Real World Evidence 2016

September 22 - 23, 2016
Philadelphia, Pennsylvania

Partnerships in Clinical Trials US

October 05 - 07, 2016
PCT Loft at the Boston Convention and Exhibition Center, Boston, Massachusetts

NORD 2016 Rare Diseases & Orphan Products Breakthrough Summit

October 17 - 18, 2016
Hyatt Regency Crystal City, Arlington, Virginia

Blogs

It’s Never Too Early for Cold Chain Planning for Cellular Therapies

By Tamie Joeckel

Cellular therapies offer potential to improve medicine and fill the needs of patients with few treatment options, though these products must be stored at cryogenic temperatures. Incorporating cold chain logistics into your clinical trial can prove beneficial in making these products available to patients.

Ensure Sites’ Readiness for New Monitoring Initiatives

By Ashok Ghone

Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.

Clinical Trials in Eosinophilic Esophagitis (EoE) - Advances and Opportunities with this Rare Disease

By Evan S. Dellon, MD, MPH

Eosinophilic esophagitis (EoE) is a rare esophageal condition that currently has no FDA-approved medications resulting in major gaps in treatment. Therefore, the need for better options and opportunities for drug development is apparent.

Noteworthy

Early Phase Clinical Trials in Patients With Hepatic or Renal Impairment

By Narine Baririan Pharm. D

Studies in Hepatic and Renal Impaired special populations have almost always required drugs with systematic absorption resulting in unclear conclusions. A solution for this would be a study design based on pharmokinetic properties that incorporates principles of Hepatic and Renal Impaired pathologies.

Getting There: A Behind-the-Scenes Look at Cancer MoonShot 2020

By Stephanie Pyle

The Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.

Merck’s Adam Colley on TransCelerate’s SQT Initiative: Mutual Recognition for EDC System Training

By Moe Alsumidaie

TransCelerate’s Site Qualification and Training Initiative has launched a special project aimed at improving Electronic Data Capture system efficiencies between sponsors and sites. Adam Colley of Merck explains the improvements that this initiative will provide for training providers and sites.

E-Books

Oncology Clinical Trials

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

 

Cardiac Safety Assessment Update

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.

 

Clinical Trial Management

Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.

 

 

View all e-books

 

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