Clinical Development Consulting

Strategy, Plans & Operations

Leverage our seasoned drug development physicians to define your clinical development strategy and manage your clinical trials.

Clinical Development Strategy, Planning & Operations Support

Our seasoned pharmaceutical physicians and functional specialists work to ensure that your program is on the optimal path forward, balancing risk and value, while responding to changes in the external environment. Cytopharma’s core team leverages 150+ industry-experienced, clinical development strategy and operations consultants, with backgrounds spanning a broad range of therapeutic areas and product modalities. Our extensive consulting resources allow us to offer you versatile, fit-for-purpose expertise that can be tailored to the exact needs of your clinical development program, enabling us to support you in each crucial area from planning and strategy to execution and tactical support.

Clinical Development Strategy & Clinical Development Plans:

  • Developing target product profiles
  • Clinical development strategy
  • Clinical development plans
  • Developing study synopses and trial protocols
  • Clinical trials benchmarking
  • Disease indication strategy and lifecycle management
  • Statistical Analysis Plans and Biostatistics Support

Clinical Operations:

  • Clinical operations support (CRO and site management)
  • Resolving recruitment issues
  • Clinical Quality Assurance and cGCP compliance

Regulatory:

  • Defining regulatory strategy and optimal pathways
  • ODD, FTD, Breakthrough, Priority Review applications
  • IND and NDA/MAA/BLA readiness analysis
  • Providing strategic or hands-on support for interacting with the FDA and EMA
  • Preparing dossiers and submissions
  • Click here for full details on our RA capabilities

Interim Chief Medical Officer

Cytopharma has a number of CMO-level clinical MDs in our consulting network, who support our biotech clients as interim Chief Medical Officers, during for example, periods of extended search for a full-time individual. These Cytopharma consultants are capable of overseeing flagship clinical trials, guiding a portfolio of programs, providing leadership to junior medics in the organization, as well as representing the company with the board of directors, investors and regulatory authorities.

Why Cytopharma ?

Our drug development consultants each bring an average of 30 years of industry experience and wisdom to our clients’ program teams. Many have made significant contributions to the development of launched products and have held global responsibilities for marketed medicines. With Cytopharma , you can access high-caliber, clinical development experts with proven track records and precisely relevant expertise. Whether you need to rapidly augment your existing capabilities, move past a development or regulatory hurdle with minimal delay, or obtain high-level strategic guidance, we have the experience and personnel to help you.

Contact us

Discuss our consulting services for the pharma & biotech industries with us.

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