Topic: Strategic Partnerships

Clinical Development from pre-IND to NDA

As a CRO, Health Decisions often performs work at different stages and in different disciplines of clinical development. Such tasks include strategic consulting, program planning, protocol development and other biostatistical consulting, project management and clinical monitoring of clinical trials (phase 1 – 3 clinical trials for drugs and PMA and 510(k) studies for diagnostics and… Read more »

A Strategic Clinical Development Partnership Success Story

This post concludes a three-part series on strategic clinical development partnerships. The first post in the series discussed surveys showing widespread disappointment in existing strategic partnerships. The second post in the series identified success factors in strategic clinical development partnerships. This post provides a deidentified example of a successful strategic partnership. How to Assemble a… Read more »

Strategic Clinical Development Partnerships: Success Factors

We have had enough success in strategic clinical development partnerships to discuss success factors rather than the disappointing results of such partnerships reported in the industry surveys and studies referenced in last week’s post, A Reality Check on Strategic Clinical Development Partnerships. Strategic partnerships can work if structured to include key success factors. In our… Read more »

A Reality Check on Strategic Clinical Development Partnerships

The strategic partnership model in clinical development was supposed to increase efficiency, not just lock pharmaceutical companies into deals with big CROs. However, mounting evidence indicates that strategic partnerships as commonly practiced have failed to deliver the goods. In an October 1 article for Applied Clinical Trials, Ken Getz of the Tufts Center for the… Read more »