CLINEXEL is a full-service Clinical Research Organization. We provide clinical research, clinical development, regulatory affairs, medical writing and pharmacovigilance services. Our Clients include companies with their innovations (new chemical entities & biologicals) in early clinical development phase, small/ mid-size pharma and biotechnology companies with niche products and medical device companies focused on complying with new EU Medical Device Regulations. CLINEXEL Management includes professionals with experience in leadership positions in pharmabiotech companies. Extensive experience and technical expertise of our technical leaders coupled with their hands on experience in key positions in pharma companies enables us to provide customized, efficient, regulatory compliant and cost-effective solutions to our Clients. Passion and hard work of the team enables us to consistently deliver great results for our Clients.
We are providing services to companies based in India, USA, Italy, Germany, UK, Singapore and Canada. 60 percent of our business is exports.
CLINEXEL Project Managers ensure efficient Project Management and experienced CRAs provide high quality monitoring services
We are providing global clinico-regulatory services for development of new chemical entities and biologicals.
We support companies by preparing clinical development plans and regulatory strategies and further firming up these through pre-IND and scientific advice meetings. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals
We provide Global solutions for CLINEXEL clients through world-wide clinical trials.
CLINEXEL is a member of Association of International Clinical Research Organizations (AICROS) www.aicros.com. Through AICROS, we can provide clinical trial sites in 4 continents and over 80 countries.
We are conducting end to end PV operations for multiple Pharma companies for the US FDA and India compliance, including ICSR (case) processing, PBRERs, literature monitoring, signal detection, RMP and evaluation of additional PV activities and RMM measures.
We conduct Pilot & Pivotal clinical investigations for medical devices. We are conducting Post Marketing Clinical Follow-up (PMCF) studies for marketed devices. We are preparing CEPs and CERs for our clients. to support CE marking.
CLINEXEL team has experience with following devices- stents, ventilators, intraocular lens, respiratory devices, orthopaedic devices, electromagnetic radiation emitting devices, sutures and gloves.
WE are a team of committed and talented professional include pharmaceutical physicians and pharmacists, clinical research professionals, expert clinicians and medical writers.
With an extensive 150+ years of cumulative industry experience in handling time sensitive projects Strong Project Management & quality review.
Our Team consists of high performing professional management team led by experts from the Industry.