Clinical Development

Below you will find examples of the services ReproVision may provide. This listing serves as an overall description and can be finetuned depending on your specific needs:

Design of comprehensive Phase I – IV clinical programs, meeting the most recent regulatory criteria and guidelines 

Outline of clinical programs for

- dose-escalation;

- definitive dose finding;

- proof-of-concept;

- demonstration of efficacy, safety and tolerability;

- post-authorisation safety studies

Design of Phase I - IV clinical studies

Specific designs of studies for demonstration of

- mechanism of action (gonadotropin suppression; ovarian function; cervical mucus effects; endometrial effects);

- efficacy/safety/tolerability;

- metabolic effects (carbohydrate/lipid metabolism, hemostasis, other endocrine systems);

- non-contraceptive effects or indications (e.g., acne, dysmenorrhea, endometriosis, PMS/PMDD)

Preparation of and participation in interactions with regulatory authorities

Determination of strategy and composition of briefing books to support meetings with regulatory bodies, as well as participation in such meetings, e.g.: Pre-IND Meetings, End of Phase II meetings, Pre-NDA Meetings, Special Protocol Assessments, Scientific Advice Meetings, pre-submission meetings.

Clinical evaluations

Evaluate the strengths, weaknesses, opportunities and threats, identify gaps and assess probability of success of (candidate) products considered for in- or outlicensing, or phase transitions.

Writing of supporting clinical documentation

The actual preparation of your clinical support documentation, e.g., clinical development plans; clinical trial protocols; clinical trial reports; CTD modules; integrated summaries; product information (Summary of Product Characteristics, US PI); agency responses; clinical evaluations; publications

Lectures and training on all of the above

Clinical development and therapy area training on various levels

Clinical project management

Leading of multidisciplinary clinical development teams and/or clinical trial teams to ensure consistency, maintenance of quality, adherence to regulations and timely completion of activities.