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Guidance For Early Adopters Of The TransCelerate SIP

In today’s post, the sixth in the series on the TransCelerate Shared Investigator Platform (SIP), we offer guidance and best practices for early adopters of the SIP. For more background information on TransCelreate or the SIP, or for guidance directed toward companies that have not joined TransCelerate or adopted the SIP, see the previous posts.

For those of you who are members of TransCelerate and are committed to tackling the challenges that come with the SIP to make life easier on your investigators, here are some ideas to consider:

GOVERNANCE BOARD

Establish a formal SIP Program with a formal governance board. The board should include representatives from all internal stakeholder groups, and potentially a neutral third party (a trusted advisor) to help facilitate discussion and decision making.

DECISION MAKING

Implement a standardized, objective decision-making process for the board to follow.

USER INPUT

Ask your site users what they think and how they feel about working on your studies. Ask them about their tolerance for change, how much advance notice they need, the type of training they prefer, etc. And keep asking over time.

RELEASE SCHEDULE

Implement a standardized release schedule for all site-facing applications and processes, including the SIP, that balances your business needs with your users’ tolerance for change. The board should collectively decide which changes to include in each standardized release.

WORKING COMMITTEES

Establish working committees to tackle specific challenges related to the SIP. Pull in technical experts, as needed, to help tease these out and identify the best path forward. Once the path forward is agreed upon, weave the related changes into the standardized release schedule.

CHANGE MANAGEMENT

Implement a standardized change management approach that includes communication with and training for site users, based on their feedback.

In our next and final post in this series, we’ll provide links back to all of the posts in this series, as a reference, as well as offer additional resources for you. In the meantime, check out this brief video that describes a project we completed for one of the TransCelerate member companies, and fill out the form below to download our related guide, Perspectives on the TransCelerate Shared Investigator Platform.

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Param Singh

Param Singh has been working in the life sciences industry his entire career. As the director of clinical trial management solutions at Perficient, he developed the clinical trial management team to become one of the best in the industry. Param leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. He has a knack for resource and project management, which allows clients to achieve success. Param has been with Perficient, via the acquisition of BioPharm Systems, since 2008. Prior to joining the company, he guided the clinical trial management group at Accenture.

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