Algorithme Pharma | November 2012 e-Bulletin
e-Bulletin / November 2012
Complexity of Early Stage Trials
As Phase l trials evolve, the traditional linear process of conducting Early Stage Trials is changing.
With enormous pressure to shorten timelines and to include the assessment of efficacy parameters in early stage trials, complexity can hinder advancement. Carefully planning the steps from the First in Human (FIH) trial to the Proof of Concept (POC) study is critical to expedite entry into Phase II and help improve the overall drug development process.
To overcome these increasing challenges, Algorithme Pharma has proactively implemented an approach of multiple-part integrated and adaptive designs in early stage clinical trials. This approach offers the advantage of completing a full Phase I program:
  • In short timelines
  • Within budget requirements
  • Through simultaneous conduct of different parts

All this is achieved together with the possibility of investigating new parameters in optional adaptive cohorts in a results-focused mode, all within the same study protocol.

This approach is successfully implemented in multiple early stage clinical trials to support critical GO/NO-GO decisions.
In today's competitive conditions, the key to success is an understanding of the compound and development objectives. We distinguish ourselves through extensive scientific, regulatory, data management, clinical and bioanalytical expertise, all of which can help mitigate the challenges in conducting successful Early Stage Trials.
To learn more about our Early Stage Trial services, please contact us at
Contact us at 1 (450) 973-6077, 1 (888) 267-7449, or