A Successful Migration: Transitioning Life-Saving Clinical Trials to a New Owner

Healthcare Innovation + Transformation

When a cancer treatment-development organization acquired a small biotech firm, the successful handoff of clinical trials was critical for the ongoing development of these life-saving treatments.

BY FUTURE STATE

A large drug-development organization focused on the development of cancer treatments acquired a small, successful biotech firm with two treatment pathways in clinical development. After an initial analysis, the company decided to integrate all functions and clinical trials from the acquired company into the parent company’s processes. This meant transferring active clinical trials, all of which were working to enable availability of future life-saving treatments.

A Delicate Process
The biotech firm had 23 active clinical trials in progress, and the larger organization needed to migrate these studies to its own system—safely and while maintaining compliance and regulatory standards. The level of complexity of drug trials would make this challenging for any business, and this organization had no precedent for migrating trials from an acquired company. It needed a rock-solid plan to move the active trials. What’s more, the researchers who had been managing these trials were highly personally invested, and were being asked to turn over the work to a new set of managers—something that required trust and confidence in the new team.

Coming Together
Future State was hired to provide change management expertise and conduct a series of workshops to build a plan for study transition. An initial three-day workshop brought together study teams from the acquired company and staff at the parent company who would be managing the trials going forward. Using graphic facilitation, process mapping and expert facilitators, Future State was able to address concerns, build a plan, and ease tension in a productive and motivational workshop.

We also conducted several follow-up workshops so the company would be set on a path for success moving into the future. In one, a one-day interdependencies workshop, representatives from several functional areas came together to discuss and map out how each function could best work together throughout the study transition process. In another, we spent three days identifying and roadmapping best practices, timelines and approaches to transition more than 100 study sites from one company to the other. Finally, a three-day data management workshop mapped out a specific strategy for transitioning study databases.

Transition Success
In the end, a company that came to us with a huge and complex transition to manage walked away with three distinct transition-approach models based on study progress, and all 23 in-progress studies successfully transitioned to the parent company. We worked together to create high-level visual timelines for 11 functional areas in each transition model and identified key interdependencies within. We also identified critical needs in project management and regulatory cooperation in order to meet transition deadlines; led a facilitated workshop to determine needs country by country and study by study; and created 110 project plans specific to each country.