Oak Crest Services

Regulatory & Trial Design Core

The Regulatory & Trial Design Core at Oak Crest with its network of affiliated experts is highly experienced in trial design (pre-clinical and clinical), IRB submissions, strategic clinical trial design, patent preparation/submission, as well as FDA submissions, including pre-IND and IND packages.

Our own track record and long-developed, trusted connections provide the highly productive units comprising the Regulatory & Trial Design Core. All or some of these may fit our clients’ needs for an outsourced but personally involved, hands-on, connected team of experts keeping timelines, expectations and deliverables up-to-date as efficiently as possible.

The following skills are available at consulting rates for Foundation, State, and Federal Government applications (NIH, NSF, DoD, FDA, etc.):

  • Study/Trial Design: Expertise and assistance in pre-clinical and clinical study design as well as cost-effective out-sourcing possibilities (including GMP facilities)

  • Strategic Planning: Development of a Strategic drug/device development plan including timelines, deliverables, regulatory requirements at which step

  • IRB: assistance or full responsibility for submissions/renewals/ongoing management; assistance in filing AE reports, deviation reports and similar IRB requirements

  • Clinical Trial Design: Provides very experience support in various trial targets and required designs, including FIH (First-in-Human), Phase I, I/II, II trials.

  • Strategic Planning: Development of a Strategic drug/device development plan. The Regulatory Core integrates client’s goals in product development with a more focused Strategic Development plan, all of which influence critical trial design features (timeline, financial, recruiting, regulatory)

  • FDA: assistance with dossier preparation for client review, oversight of submission process and monitoring timelines as well as specific FDA comments in subsequent actions. Available for pre-IND meeting preparations, IND submissions

  • Patents: Via our own productive record, the Core has extensive experience in patent submissions (provisional and final), including timing strategy, what support might or must be included, help clarify claims.

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