Consulting Services
Senior staff and advisory committee members at PROMETRIKA, including statistical, medical, regulatory, clinical operations, and project management experts, are available for consultation on an hourly basis in their respective areas of specialization. Listed below are some of the areas in which we offer consultation.
Standard Operating Procedure (SOP) Development: We assist our clients in developing SOPs and training manuals for new or existing departments. We can also provide guidance in designing or refining workflow processes and procedures to maximize efficiency and ensure compliance with regulatory requirements.
Project Management: We offer consultation services and assistance to our clients who wish to change their processes from a function-area based model to a project team model with the objective of creating an empowered project management system. We also assist clients in designing and implementing procedures to manage their project timelines and expenditures.
FDA Interactions: For our overseas clients and those U.S. clients who need advice on the specific philosophy and preferences of the FDA, we can offer the services of our senior staff and advisory committee members. These distinguished professionals have liaised with many divisions of the FDA and have an in-depth knowledge of the Agency’s scientific approach and the rationale behind its policies. They are well qualified to assist our clients with strategies for successful FDA interaction.