Our Services

We are an experienced, nimble, client-focused consulting group supporting all aspects of clinical trial processes from design to submission, specializing in small to midsize biotech and pharmaceutical innovators.

Clinical and operational resources
to support scale.

  • Organization of project deliverables, milestones, and contracts to create a clear strategy for operationalization of clinical trials.

  • Development of new clinical documents and SOPs or review of existing documents; providing scientific and medical input, ensuring operational feasibility and alignment with clinical objectives.

  • Strategic Request for Proposal template creation and a CRO/Vendor proposal review plan to ensure that services meet study and team needs.

  • Organization of vendor deliverables and milestones to create a clear strategy for oversight of vendor adherence to contractual obligations and timelines to achieve corporate goals.

  • Measure what matters with carefully selected key performance indicators and easy-to-use metrics report tools.

  • An a la carte personnel resource for clinical trial experts; expert assignments to provide temporary or ongoing support.

Personnel Services

Our full-time equivalent services are available by the hour or by a negotiated discounted retainer.

  • Support by PhD/MD to provide expert review and oversight of clinical products; clinical development plan, core documents, database design, clinical key performance metrics, data reports or presentations, SOPs.

  • Support to oversee and guide project management teams, vendor teams, & external partners. Development and oversight of project management plan, resource management plan, and department finances.

  • Support to manage key tasks & clinical trial operations. Includes internal/external cross functional line support. Development and oversight of vendor management plan, clinical monitoring plan, vendor performance metrics, internal/external team member contributions.

    Support to manage and monitor clinical trial financials, including per subject costs, vendor costs, consultant costs, internal resourcing costs as well as development of process flows to manage financial approvals, changes in scope, change order approvals, and contractor/vendor support.

  • Support to provide strategic monitoring guidance and assessment, monitoring oversight, and on-site/remote monitoring and site management.

  • Support to perform administrative tasks required to ensure the appropriate management of key tasks & clinical trial operations.