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TransCelerate BioPharma Inc. Launches Second Year Initiatives, Expands Membership and Achieves Milestones for Original Projects
Date:11/7/2013

ject, and accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and creation of investigator documentation, and thereby reducing cost and trial length.

In addition to the three new initiatives, TransCelerate will expand on two successful projects that were part of the original five initiatives:

  • Site Qualification and Training – To build upon the creation of common criteria for mutual recognition of GCP training and common forms to collect generic information about study sites, TransCelerate will provide a common framework to streamline the process for qualifying investigator sites, , and standardizing non-protocol specific forms for clinical trials. The organization will also establish criteria for training site personnel new to clinical research and trials.
  • Comparator Network – To enhance the value of the network, TransCelerate will expand on the current offerings to include products for clinical trial blinding: active & placebo, devices and bulk commercial products. The organization will also include the option of product discounts and expansion of the network in other regions of the world.

The new initiatives and extensions expand on the scope and success of the original TransCelerate initiatives, which have provided the following advances for both industry and patients:

  • A published framework and approach for Risk-Based Monitoring (RBM); launch of pilot studies for RBM across multiple member companies and therapeutic areas
  • Established criteria for

SOURCE TransCelerate BioPharma Inc.
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