Clinical Trial Preparation

Clinical Trial Preparation & Strategy

As part of trial planning, PES helps our clients evaluate and select primary endpoints, develop a trial protocol, lay the groundwork for high-quality clinical data capture, assist with CRO selection, and advise on initial regulatory meetings and submissions. We serve as an extension of the sponsor’s clinical team, collaborating on all the early planning decisions that can impact the success of a trial study.

PES works directly with the clinical team to:

How we work

PES brings expertise and energy to the first steps of a trial’s planning phase. We work as part of the clinical team to assess study objectives, select endpoints, map trial activities to the endpoints, and then bring together the needed pieces to drive success:  selecting the right CRO, designing tools to effectively capture data from the sites, establishing effective communication and handoffs between CRO and sites, and supporting the study’s effective launch.

Why we do this

Well-run trials begin with a good team, the right endpoints, and confident first steps. It is vital that these initial cornerstones get placed correctly – missteps in the planning phase of a trial can lead to expensive and unrecoverable mistakes. PES mitigates this risk by getting in front of future headaches and problems – avoiding frustration and saving our clients time and money.

Clinical Trial Preparation & Strategy

As part of trial planning, PES helps our clients evaluate and select primary endpoints, develop a trial protocol, lay the groundwork for high-quality clinical data capture, assist with CRO selection, and advise on initial regulatory meetings and submissions. We serve as an extension of the sponsor’s clinical team, collaborating on all the early planning decisions that can impact the success of a trial study.

PES works directly with the clinical team to:

• Assist in the selection of the study endpoints as part of the protocol development, with careful consideration of clinical, regulatory, and commercial meaningfulness
• Engage experienced indication-specific clinical thought leaders as team members
• Establish collaborative relationships with the sponsor, CRO, and sites to facilitate all aspects of data collection, analysis, and interpretation

• Design worksheets and tools that enable uniform, disciplined, and complete data collection for the trial’s specific clinical endpoint
• When needed, assist in the identification and development of surrogate biological endpoints and relevance to clinical endpoints

How we work

PES brings expertise and energy to the first steps of a trial’s planning phase. We work as part of the clinical team to assess study objectives, select endpoints, map trial activities to the endpoints, and then bring together the needed pieces to drive success:  selecting the right CRO, designing tools to effectively capture data from the sites, establishing effective communication and handoffs between CRO and sites, and supporting the study’s effective launch.

Why we do this

Well-run trials begin with a good team, the right endpoints, and confident first steps. It is vital that these initial cornerstones get placed correctly – missteps in the planning phase of a trial can lead to expensive and unrecoverable mistakes. PES mitigates this risk by getting in front of future headaches and problems – avoiding frustration and saving our clients time and money.