clinical trial consulting Overview

Regulatory know-how. Strategic planning.

Changing regulations represent a complex environment in which to develop new therapeutics. inVentiv Health Clinical has assembled an exceptional team of international regulatory and pharmaceutical experts skilled in clinical development, planning and execution, and regulatory submissions.

Our team's experience with regulatory agencies on five continents covering every stage of development and type of therapeutic, from early planning to post-marketing, includes:

  • Small molecules
  • Therapeutic proteins and biologics
  • Biosimilars
  • Vaccines
  • Cell and gene therapies
  • Combination products
  • Drug delivery systems
  • Clinical development programs

Strategic planning during the earliest stages of clinical development optimizes project efficiencies. inVentiv Health Clinical professionals begin by understanding your objectives and goals, and then build a cohesive strategic plan for program execution. By devoting more effort early in the project, inVentiv Health Clinical can help anticipate potential issues and build contingency scenarios into the plan. They develop global clinical programs to avoid duplicative steps, comply with local regulations and international standards for data and reporting, while maximizing labeling claims and geographic distribution.

inVentiv Health Clinical professionals can also help you better understand potential risks and formulate a proactive strategy minimizing the risks associated with you program. An important aspect of risk management is Gap Analysis; a critical component of your NDA/BLA/PMA. We can review your product development plan, evaluate whether your study design is sufficiently thorough and robust, identify potential regulatory risks, suggest corrective measures, and assess your chances for first-pass approval.

Expert advice based on direct experience is why inVentiv Health regulatory and pharmaceutical experts can guide you through complex regulatory processes anywhere in the world.