Clinical Trials

CLINEXEL provides end to end services for conducting clinical trials starting from study design, feasibility studies and site selection, preparation of protocol and other essential documents, logistics and project management, clinical trial applications and approval, clinical trial monitoring, data management, statistical analysis and preparation of clinical study report.

Clinical trial project planning including feasibility assessment, development of regulatory strategy and financial planning.
Selection of countries & Clinical Trial Applications to Competent Authorities for approval.
Vendor Selection and logistics Management.
Site Selection & qualification.
EC dossier preparation, submission and approvals.
Efficient Patient Recruitment Strategies.
Investigator contract development and grant negotiation.
Site set-up.
Investigator meeting.
DSMB set-up.

Site initiation visits.
Clinical Trial Monitoring by experienced team of CRAs.
Receipt, processing, medical assessment and reporting of SAEs.
Investigational Product Management and Accountability.
Clinical Trial supply management.
Resolving Data Queries.
Reporting of Deviations and supporting the site for Corrective and Preventive action(CAPA).
Study Close-out visits.