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CLINEXEL is a full-service Clinical Research Organization providing end-to-end services for Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, and Pharmacovigilance. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, the USA, Canada, Israel, and Singapore.
CLINEXEL is an agile, customer focused full service CRO
Our clients include companies with their innovative therapies (new chemical entities & biologicals) in early clinical development phase, small or mid-size pharma and biotechnology companies with niche products, and medical device companies focused on complying with new EU Medical Device Regulations (EU-MDR) and In Vitro Diagnostic Regulation (IVDR).
CLINEXEL Management includes professionals with experience in leadership positions in pharma biotech companies. Extensive hands-on experience and professional expertise of our technical leaders enable us to provide customized, efficient, regulatory compliant and cost-effective solutions to our clients. Passion and hard work of the team ensures that we consistently deliver great results for our clients.
We provide customized, efficient, regulatory compliant and cost-effective solutions for Clinical Trials, Pharmacovigilance, Regulatory and Medical Writing Services.
Clinexel is a full service CRO with Full-Time Equivalents (FTEs) and qualified vendors providing services from protocol preparation, site selection, regulatory and EC approvals, clinical monitoring, CDM until Clinical Study Report (CSR) writing. Clinexel employees Clinical Research Associates (CRAs), Monitors, Project Managers (PMs), and Medical Writers (MWs) are Full-Time Equivalents (FTEs), working from Clinexel office.
At Clinexel, Pharmacovigilance team provides various services including case processing, regulatory submissions, aggregate reports, literature monitoring, signal detection and Risk Management Plans (RMPs). We conduct GVP audits and provide QPPV services in several countries.
We work as AICROS (Association of International CROs) for conducting Multi region Clinical Trials (MRCTs) in countries where Clinexel staff are not present on the ground. AICROS is an alliance of 8 local and well established CROs. Clinexel is a full member of AICROS. CLINEXEL leaders have experience of interacting with the USFDA, MHRA, competent authorities (CAs) from Europe, India and other countries.
We provide Clinico-regulatory services including CT dossier preparation & CA approvals, pre-IND dossier preparation & coordination for pre-IND/ scientific advice meetings, IND filings services including CC with the Agency
Drafting high quality of Protocols, Informed Consent Forms (ICF), Investigators’ Brochure (IB), Clinical Study Reports (CSR), Clinical Evaluation Plans & Clinical Evaluation Report (CEP, CER) including literature search protocol, PICO analysis, Manuscripts for Publications.
At Clinexel we conduct Pilot and Pivotal clinical trials for investigational devices, PMCF studies for CE marking (new/ renewal), Clinical Evaluation Plans & Clinical Evaluation Report (CEP, CER), Biological Evaluation Plans & Reports (BEP, BER) and Performance Evaluation Plans and Reports (PEP, PER).
(ISO 9001:2015:QMS)
(ISO / IEC 27001 : 2022 :ISMS)
CLINEXEL is a Member of AICROS
CLINEXEL is a professionally managed Company, a CRO is led by experts with experience in leadership positions in pharma and biotech companies.
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