CLINEXEL is a Contract Research organization providing end-to-end services in Clinical Development, Clinical operations, medical writing, and Pharmacovigilance. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, the US, Canada, Israel, and Singapore.
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.
CLlNEXEL is currently supporting 7 Pharma companies for Pharmacovigilance as below: End to end PV operations for US FDA and India, including case processing, periodic reports, literature monitoring, signal detection, preparation of risk management plan and evaluation of additional pharmacovigilance activities and additional risk minimization measures.
CLINEXEL supports companies by- • Development of efficient clinical development plans acceptable to different regulatory authorities • Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine tune clinical development plan • Filing and maintaining IND in US, clinical trial applications in EU and India • Global solutions for CLINEXEL clients through world-wide clinical trials.
At CLINEXEL, we are providing global clinic-regulatory services to companies for the development of their new chemical entities and biologicals. We have supported companies for pre-IND and scientific advice meetings for firming up their clinical development plans and regulatory strategies. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals.
Preparation of Protocols, Informed Consent Forms, and Investigators’ Brochure • Preparation of Clinical Study Reports • Authoring Clinical Evaluation Reports including literature search protocol, PICO analysis • Post Marketing Clinical Follow-up Plans.
CLINEXEL Team members have extensive experience in Pharmacokinetic studies in healthy volunteers and patients. Cumulative experience of the team spans ~800 studies for various markets, including PK studies in healthy volunteers, patients for Long Acting Injectables, biosimilars and inhalation products.
(ISO / IEC 27001 : 2013 :ISMS)
CLINEXEL Is a member of AICROS