Noteworthy

Global Biomarker and Companion Diagnostics Outsourcing Market

Over recent years global drug companies large or small have recognized that one root cause of the high failure rate in their clinical development lies in the selection of right therapeutic targets.

Tips on Cracking the CRO Procurement Process

By Moe Alsumidaie

The need for innovation in clinical trials has sparked significant interest from a variety of new enterprises including technology, analytics, subject enrollment/engagement/retention, EDC, risk-based monitoring, and many mor

Forecast Enrollment Rate in Clinical Trials

By Gen Li

Instinctively, when there are more investigators/sites being deployed for a trial with a defined number of patients needed, we should expect shortened enrollment cycle time. This sounds right, but is it really?

Blogs

Does the TransCelerate RbM Guidance Offer Standardization?

By Moe Alsumidaie

The concept of risk-based monitoring (RbM) is evolving, as nonprofit organizations continue to collaborate with the biopharmaceutical/medical device industry to investigate, pilot and implement RbM practices.

FDA Encourages Supplements for Oncology Drug

By Jill Wechsler

One way to reduce off-label prescribing of treatments for cancer and other conditions is for manufacturers to test additional indications and file supplemental applications to add those uses to approved labeling

Centralization of IRB Review Fact of Life Outside of NIH

By Erica Heath

The idea is great: when an investigator submits a grant to any NIH institute, if the study will involve more that one performance site, the grant must include a plan to rely on one single IRB.

Data Analysis

Time for Another CRF Migration

Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.

The Cost to Develop an Approved New Drug Now Exceeds $2.5B

Tufts CSDD estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion.

Events

Clinical Enterprise Architecture and Data Governance

February 26, 2014 - February 26, 2016
TBD, Philadelphia, PA, USA

Patient-Centric Trial Design

February 03 - 04, 2015
Sonesta Hotel Philadelphia, Philadelphia, PA, USA

The Forte Forum

March 03 - 06, 2015
Laguna Cliffs Marriott Resort & Spa, Dana Point, California, USA