Your Trusted Partner For Clinical Research and Pharmacovigilance
We are a full-service clinical research organization that provides 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 a full-service Clinical Research Organization (CRO) with presence in India and the USA. We are providing end-to-end services for Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, and Pharmacovigilance. CLINEXEL is the partner of choice for innovative, biotech companies working closely with them as their trusted partners. Our mission is to help bring the much-needed drugs to the patients, by guiding innovative Pharma & Biotech companies navigate the challenges of funding constraints and regulatory complexities. We achieve this thorough scientifically rigorous, cost-effective clinical development strategies and execution of high-quality clinical trials.
We are providing Global Clinical Development Solutions to our clients – Pharma, Biotech and Medical Device companies. By partnering with strong Local CROs through AICROS, we conduct clinical trials across the globe.
We have demonstrated success in conducting clinical trials across all 4 phases (phase I-IV) including First in Man, in Healthy Volunteers and in Patients
CLINEXEL is an agile, customer-focused full-service CRO
Our clients include companies with innovative therapies (new chemical entities & biologicals) in the 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. The extensive hands-on experience and professional expertise of our technical leaders enable us to provide customized, efficient, regulatory-compliant compliant and cost-effective solutions to our clients. The passion and hard work of the team ensure 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.
For product registrations in India : CDSCO mandates
A reasonable percentage of Indian patients should be included in Phase 2/Phase 3 trials. In case India is not a participating country in Phase 2/Phase 3 trials conducted for registration in other countries (EU/USA/ROW), regulatory requirement is to either conduct an additional study (Phase 3) in India, and the drug product is granted marketing license for India thereafter.
In rare disease conditions when the drug product is to be made available to the patients immediately, CDSCO directs the Sponsor company to carry out a post-marketing clinical trial immediately after the grant of marketing license for the drug product.
CLINEXEL – as the Local CRO in an MRCT** works closely with Global CROs & Sponsor for the following:
** Clinical Trials conducted across multiple countries or regions at the same time are the Multiregional Clinical Trials (MRCTs). These are necessary as they allow concurrent drug development and drug approval across various populations (ethnic groups, geographical locations, and regulatory environments).
Solid track record of conducting clinical trials across all 4 phases (phase I-IV) including First in Man in Healthy Volunteers and Patients
CLINEXEL – Your Partner for Regulatory & Cost-Effective Clinical Trial Execution
Clinexel is a full service CRO with Full-Time Equivalents (FTEs) & qualified vendors providing services from protocol preparation, 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.
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.
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
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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