The cornerstone of a successful Clinical Development Program is a well thought out plan.
DiagnoSearch houses the entire milieu of elements required for strategic planning such as decades of clinical trial experience, cross functional teams, wide therapeutic area experience, an understanding of and experience of working in regulatory requirements of various countries.
The think tank at DiagnoSearch comprises of Medical, Statistical, Clinical Operations and Regulatory Personnel who offer a comprehensive blueprint for every aspect of an entire Clinical Development Program or an individual clinical trial.
The Consulting Services offered at DiagnoSearch include:
Conceptualization of the entire Clinical Development Program - all studies necessary from “a molecule to a marketed medicine” (based on relevant regulatory requirements)
Clinical trial design inputs:
Defining study objectives
Selection of endpoints, study population, defining eligibility criteria, selection of appropriate controls
Optimal study design
Statistical methodologies including sample size estimation, power calculations, appropriate statistical models
Suggestions on suitable geographies for study conduct and feasibility/viability of conducting a study in a specific geography
Operational Challenges/Risks foreseen in the conduct of a study and appropriate mitigations
Regulatory Consulting with respect to study design requirements, Clinical Trial Application requirements, Import / Export regulations and responses to regulatory queries on Clinical Trial Applications
Investigational Product Management consulting:
Determination of quantities of Investigational Products and comparators required including overage calculations
Ideal sources for procurement of comparators
Consulting for Investigational Products packaging and labelling including country / region specific labelling requirements
Investigational Product Management Plans
Laboratory consulting services and training at government and university laboratory setups across geographies on applicable laboratory standards, SOP development, assay set-up and validation, quality control, proficiency and standardization of assay across multiple laboratories
Project specific financial audits of sites and sub-contractors