Clinical Development Consultants
Aptuit Consulting’s team of clinical development experts each have more than 20 years experience in the development of new small and large molecule drug products. This consists of experience in a wide range of protocols from Phase I and Phase II proof-of-concept studies to the direct management of large scale Phase III study programs in most therapeutic areas across the globe including many new and emerging markets.
Aptuit Consulting’s Clinical-support services include:
- Creation of clinical development strategies in collaboration with and acceptable to regulatory authorities.
- Preparation of clinical protocols involving investigator input in many therapeutic areas.
- Creation of Case Report Forms and study Master Files
- Managing the creation and distribution of clinical trial drug supplies
- Execution and management of clinical studies
- Data analysis and reporting of results of clinical trials
- Preparation of integrated summaries of efficacy and safety information
- Leading pre-IND and NDA meetings with the FDA to defend clinical development work
- Clinical development programs with a proven record of success
In addition, Aptuit Consulting's Clinical Auditing services include::
- Clinical supplies testing and validation
- Efficacy database review against CRFs
- Safety database review and revision
- Statistical program review
- Provision of statistical re-analysis services
- Data tables and figures authentication
- Study report audits