CLINICAL STUDIES / DEVELOPMENT
Clinical studies.
Clear direction.
From first study
to follow-through.
Clinical development services supporting your FDA compliance and journey to
market.
Plan Coordinate Analyze Follow
01 / CLINICAL STUDIES
Plan
the study.
From First-in-Human through Phase IV.
01 / FDA
Clinical Development Strategy
Clinical development involves complexity, risk, time, and cost. Provision brings global clinical and regulatory
expertise together with proprietary technologies to simplify the journey to market, whatever the size or scope of
your study.
02 / FDA
Phase I–IV & Study Design
Support from First-in-Human through Phase IV, including clinical trial design, protocols, and choosing CROs and
universities.
02 / CLINICAL STUDIES
Coordinate
the operations.
Clinical and regulatory support working together.
01 / FDA
Study Management & FDA Meetings
Clinical trial operations management; clinical study-managing representative; FDA meetings.
02 / FDA
Market Access & Communications
Payer and market access planning; medical education; communications capabilities to support the journey
efficiently and effectively.
03 / CLINICAL STUDIES
Turn data
into evidence.
Statistical planning and data expertise.
01 / FDA
Statistical Planning
Sample size calculations; Statistical Analysis Plans (SAP); Interim Analysis Plans (IAP).
02 / FDA
Data Management & Biostatistics
Data management and biostatistics services for clinical development.
04 / CLINICAL STUDIES
Follow through
beyond the trial.
Clinical evidence and post-marketing support.
01 / FDA
Clinical Evidence & Postmarket Studies
Clinical evidence, post-market studies, and post-marketing follow-through.
02 / FDA
Development & Regulatory Presentations
Draft presentations for regulatory agencies, board meetings, or investors covering the clinical development,
regulatory, and/or statistical plan.
CONTACT US
Plan your
next step.
Discuss your clinical development plans and study needs with Provision Consulting Group.