CLINEXEL: A Reliable Partner for Pharmacovigilance & Clinical Research Services

Dr. Deepa Arora,FounderEffective pharmacovigilance (PV) function is critical for ensuring safety of the patients and meeting the regulatory compliance. Efficient performance of Drug Safety & PV function plays an important role in defining the journey of a drug after marketing as well as for outlining the performance of a pharma company in the market. CLINEXEL, a Mumbai-based Clinical Research Organization is helping its clients to reap the benefits of best-in-class pharmacovigilance & drug safety support through customized, tailor-made solutions.

CLINEXEL is the brainchild of Dr. Deepa Arora (Founder), a Physician with 20+ years of experience in the pharma industry, patient care and academia. She has successful experience of setting up and leading global pharmacovigilance functions for two MNCs for more than a decade, which includes success-fully clearing multiple regulatory PV inspections conducted by various Drug Regulatory Authorities - USFDA, MHRA, ANVISA, PMDA, Health Canada, TGA, and others.

CLINEXEL was set-up to support start-ups, small and midsize pharma and biotech companies. Today, under the aegis of its Technical Directors, CLINEXEL has etched a name for itself as one of the trusted partners for pharmacovigilance and clinical development with a flexible operating model, offering specific solutions for each client.

Dedicated Offerings
Backed by a technically strong team of experts ­ experienced physicians and
pharmacists along with the sound experience of promoters in the leadership positions in top pharma companies, has helped CLINEXEL to lead the way for itself. The array of services offered by CLINEXEL covers pharmacovigilance, clinical research, and medical writing.

With a forte in pharmacovigilance, the firm holds capabilities to provide global services, including pharmacovigilance operations, customized services for global & regional compliance, and PV inspection readiness.

CLINEXEL serves clients from India and regulated markets (US, UK, EU and Canada) who find it challenging to develop in-house capabilities for conducting a full range of Pharmacovigilance activities. CLINEXEL staff have expertise in processing ICSRs, Literature monitoring, Signal detection, PBRERs, d RMPs, Signal Assessment Reports and developing Risk Mitigation Measures, thus providing end-to-end services for its clients. As CLINEXEL management has successfully delivered in leader-ship positions in pharma companies for over a decade, CLINEXEL works as an extended pharmacovigilance department for its clients, adopting and upgrading the SOPs and systems as per the new or updated regulations or unique requirements of the client's medicinal products.

CLINEXEL has provided expert support and advice in addressing the Critical and Major findings resulting from regulatory authority inspections in pharmacovigilance and related CAPA strategy and response to Inspection Reports to its clients. Solutions provided by CLINEXEL are optimum, customized and cost effective based on the most updated understanding of regulations and more than a decade's experience in dealing with various agency inspections. Submitted responses have been accepted by the inspectors without further concerns.

CLINEXEL is also working with several clients for conducting independent system audits for PV, Gap Analysis, CAPA implementation and Inspection Readiness. In the Clinical Research domain, CLINEXEL is helping small and mid-size pharma companies in designing efficient Clinical Development Plans for NCEs, biosimilars and complex generics.

CLINEXEL offers unrivalled understanding and expertise in clinic-regulatory, and therefore, is helping its clients to develop sound clinical strategy including preparation of Clinical Development Plan, coordinating for Scientific Advice, Pre-IND meetings and negotiations with Competent Authorities, preparation of pre-IND dossiers, planning the studies with well written protocols and other scientific documents with great dedication. Being a member of Association of International Clinical Research Organizations (AICROS, ), CLINEX-EL is able to provide customized, tailor-made solutions for conducting global clinical trials, thereby facilitating Global Clinical Development of NCEs, biologicals and complex generics.