Clinexel: Your Trusted Partner For Clinical Research And Pharmacovigilance Outsourcing

Dr.Deepa Arora,Founder & Director

Dr.Deepa Arora

Founder & Director

Pharmaceutical and medical device companies are increasingly utilizing business model of strategic partnerships and outsourcing for success and efficiencies. Clinical Research and pharmacovigilance are two key functions that are largely outsourced as it is difficult and costly affair to develop and retain in-house expertise and big teams with the range of expertise required to efficiently handle Clinical Development and Safety Monitoring.

CLINEXEL Life Sciences Pvt Ltd is a Clinical Research Organization providing high quality and cost-efficient clinical research and pharmacovigilance support to pharma, biotech and medical device companies.

Clinexel Management
CLINEXEL is the brainchild of Dr. Deepa Arora. Dr Arora is a physician with two decades experience in leadership positions in pharma industry. She successfully led the clinical development and pharmacovigilance programs. She has a strong understanding of the global clinical development of NCEs, Biosimilars and generic products and pharmacovigilance.

CLINEXEL staff has experience of interacting with USFDA, MHRA, EMA, PRAC, CHMP Health Canada, TGA, CDSCO (India), and Rapporteurs from Infarmed (Portugal), ANSM (France), MPA (Sweden), MEB (Netherlands), during inspections, pre-IND meetings, end of phase meetings and scientific advice for clinical development plan as well as planning and implementation post marketing risk management plan.

Services Provided By Clinexel
CLINEXEL provides end to end Pharmacovigilance activities, including processing ICSRs, Literature monitoring, Signal detection, authoring PSURs and RMPs, preparing Signal Assessment Reports and developing Risk Mitigation Measures. CLINEXEL is also engaged by the companies conducting independent inspections of their PV systems, Gap Analysis and supporting their audit programs for vendor and partner audits.

CLINEXEL has supported many pharma companies by providing technical consultation to the Clients in addressing the Critical and Major findings resulting from regulatory Pharmacovigilance inspections, related CAPA strategy and response to Inspection Reports. Submitted responses have been accepted by the inspectors without further concerns.

In Clinical Research, CLINEXEL services include- development of clinico-regulatory strategy, preparation of protocol, ICF, CRF, IB and regulatory dossier submission, facilitating regulatory approvals, EC submission and approval, Clinical Operations for Phase 1 to IV clinical trials including feasibility studies, site selection, site monitoring and remote monitoring.

CLINEXEL is a member of Association of International CROs (AICROS, ) and through AICROS, CLINEXEL has the capability to support pharma companies for conducting global clinical trials in countries other than India.
Clinexel- The Partner Of Choice For Pharma And Medical Device Companies
CLINEXEL management has successfully delivered in a leadership position in pharma companies for more than a decade, CLINEXEL team works as an extended pharmacovigilance department of the company, adopting and upgrading the SOPs and systems as per the new/ evolving regulations or unique requirements of company's medicinal products.

CLINEXEL provides customized and efficient solutions for regulatory inspection findings in the Pharmacovigilance. These customized and cost-effective solutions are based on the solid understanding of regulations and more than a decade's experience of interacting with various Agencies.

At CLINEXEL, Compliance is the motto and goal. Compliance monitoring is very stringent at CLINEXEL, focusing both on timelines and high quality. For each activity, there is a monthly compliance monitoring at overall level as well as specifically for each Client.

Dr. Deepa Arora, Founder and Director, CLINEXEL(Category CRO) says, "We have a technically strong team consisting of physicians and pharmacists with the capability of quick scale-up of the services provided. Our unique technical expertise and experience with globally regulatory authorities globally and most importantly Strong Quality Management Systems. These are some of the factors that make our company stand different and unique in the market."

For Clinical Trials, CLINEXEL has developed strong Centralized Remote Monitoring capabilities. For each protocol, CLINEXEL team works with the Sponsor and the site, to identify the critical processes and critical data or the trial for proactive risk management. These remain the focus of remote monitoring along with routine monitoring of SAEs, lab alerts and completeness of the CRFs. Onsite monitoring visits are adjusted as per the output from the remote monitoring.

CLINEXEL teams is committed, technically strong, consisting of experienced physicians and pharmacists. Experience and technical knowledge of CLINEXEL Directors in the leadership positions in pharma companies helps them to understand the needs, structure, and challenges of pharma companies. Thus, CLINEXEL has successfully delivered the projects assigned and was awarded repeat business.

CLINEXEL's strength is experienced and qualified technical experts coupled with strong Quality Management Systems. There are strong project review systems for timely issue identification and risk mitigation.

Altogether the team has 100+ years of industry experience, team members have worked in various therapeutic areas, including Oncology, Diabetes, Respiratory, Central Nervous system, Psychiatry, Dermatology, Orthopedics, Cardiology; in different phases of the Clinical Trial from Phase I to Phase IV including BA/ BE studies, in NCEs, complex generics, injectables- patient studies and biosimilars.

Progress In The Business
CLINEXELgained 20+ Clients from India, US, Europe, UK, Canada, and Israel on a wide range of clinical research and pharmacovigilance projects. Almost half of these projects are complete and there are 11 ongoing projects. These projects include developing and implementing clinico-regulatory strategy for new products & NCEs, Phase 2 Clinical Monitoring services, end to end Pharmacovigilance services for India and US, medical writing- preparation of Clinical study Reports, Protocols, Manuscripts, Clinical Evaluation Reports, PMCF plans, clinical trial safety monitoring etc.

The company is ISO certified for Quality Management Systems (ISO 9001:2015: QMS) & Information Security Management System: (ISO / IEC 27001:2013: ISMS).CLINEXEL was awarded the `Best Pharmaceutical Scientific Support Provider 2019, India' by Global Health and Pharma, the UK under the Category International Life Sciences Awards. CLINEXEL business is in profit from the first year of inception and the revenues are growing at 400 percent and the company expects continued growth of 400 percent for the next 3 years. Company's goal is to become a 100 Crore company by 6th year of its inception.

Dr.Deepa Arora, Founder & Director
Dr.Deepa Arora is the Founder and Director of the Company and has more than 20 years of experience in the pharma industry in Pharmacovigilance and Clinical Development. She is an MBBS, MD, MRQA and has served in global leadership roles in large pharma companies. Due to her extensive experience, she understands the regulatory requirements and business needs of regulated and semi-regulated markets and can accordingly organize customized, tailor-made solutions for Pharmacovigilance and Clinical Trial activities for companies.