Our Services.
Study Development.
We help Integrate insights from key internal / external personal to develop a study design / plan for broad, well-positioned indication(s).
From a clear starting point based on your development plan, we compose protocols that target registration requirements as well as key points necessary for differentiation in a crowded market place.
We strive for feasibility and efficiencies in trial assessments and procedures, as well as data collection.
Study Start-up.
We help to develop the key questions necessary to identify and qualify sites for study participation. Once sites have completed the feasibility assessment process, we can support tracking of milestones towards site activation and develop the core training materials for your study.
With years of experience in oversight of data collection, we can assist with case report form development to ensure built-in efficiencies and shorten time to database lock.
Medical Management.
Years of experience in early-to-late phase studies, providing services such as:
- Eligibility review
- Interacting with principle investigators
- Site communication regarding to protocol / study conduct
- Regular review and trending of deviations / site issues
- Deviation / corrective action development
- Safety review and trending
Medical Affairs.
Experience with life-cycle support of oncology drugs, providing services such as:
- CTEP/IST strategy(ies)
- Key opinion leader management
- Publications and conference support
- Clinical review of promotional materials and med communication
- MSL/Sales force training materials and training
- Competitive intelligence