EARLY CLINICAL DEVELOPMENT

CCSF clinical thought leaders and strategic/operational consultants work closely with sponsors and investors to develop long range clinical development plans featuring sequenced study designs, timing and costing based on CCSF's proprietary Project Time-Cost Model. Services available to sponsors at this stage of development include:

• Literature reviews & expert interviews

• FDA planning & consulting

  • Representation at FDA meetings

• Pharmacoeconomic analysis

• Programmatic development

  • Adaptive trial design

  • Thought leader consultation on over-arching clinical & regulatory strategy

  • Trial sequencing /timelines/costs; cumulative burn rate

CCSF clinical thought leaders work with sponsors on regulatory issues and participate in meetings with regulatory authorities at every step of the development and clinical trial process. We will also provide market research on clinical practices, product acceptance, product economics, literature reviews and other clinical development advisory services. For more information, request a capabilities presentation below.