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Clinexel: Clinical Research, Pharmacovigilance and Medical Writing...

Tell us about your company. Its vision & mission.

CLINEXEL is a Clinical Research Organization (CRO) that provides Clinical Research, Pharmacovigilance, and Medical Writing services to pharmaceutical, biotechnology, and medical device companies.

CLINEXEL’s mission is to serve the patients by expediting clinical development of new medicines by applying global standards of clinical research & safety monitoring.

Vision of CLINEXEL is to become the CRO partner of choice for pharma, biotech and medical device companies to provide efficient clinical development and pharmacovigilance services.

What were the constraints you faced while starting with the company?

I am satisfied with CLINEXEL’s journey so far. We received good response from the market and worked with more than twenty Clients in last two years and receiving repeat business.

I have worked in the leadership positions in the pharma industry for almost two decades, and successfully set up the function for pharma companies. Our team at CLINEXEL has good understanding of standard industry practices, evolving regulations and challenges in the field. It is going well, and we are growing and scaling up.

What services do you provide to the customers?

At CLINEXEL, we provide end to end Clinical Research services starting from preparation of protocols to clinical study report writing. We prepare IND/ CTAs dossiers and documents for the regulatory approvals. In study management, CLINIXEL has good connect with KOLs and clinical sites and we provide site selection, site monitoring and data management services.

Through our partners, we conduct Global Clinical Trial services in all major geographical regions of the world.

CLINEXEL provides full Pharmacovigilance services, including case processing, regulatory reporting, periodic reports, risk management plans, signal detection and management, literature monitoring, preparation and maintenance of Pharmacovigilance Systems Master File (PSMF) and QPPV services for all countries globally.

CLINEXEL is also strong in device and drug device combination product development. We are writing Clinical Evaluation Reports (CERs) and preparing and executing Post Marketing clinical Follow-up (PMCF) Plans for the medical devices for CE marking for Europe and approvals in Australia.

What makes the company stand out from the competition?

Strong technical expertise and industry experience of the team are our strengths. We provide end to end clinical research and pharmacovigilance support, high quality work and ensuring compliance with the timelines.

CLINEXEL is earning a unique position in the CRO industry. There is some competition. Our rich global experience and solid understanding of pharma (Clients) needs is our strengths, this has helped CLINEXEL to acquire more than 20 clients in two years.

In addition to clinical trial execution, medical writing and pharmacovigilance, CLINEXEL is helping companies to develop efficient Clinical Development Plans in discussion with USFDA, MHRA and CDSCO. In 2020-21, we have been able to negotiate innovative efficient approaches for First in Man study with FDA and European agencies and quick CTA approval for First in Man clinical study in India.

What qualities do you have that you think are important for an effective leader to have?

Leadership at CLINEXEL entails great collaboration and motivating the team to deliver their best. As Clinical Research and Pharmacovigilance are highly technical fields, leaders working and learning their way up have advantage as they understand the challenges faced by the team and the Clients and can provide effective technical solutions.

Rapid developments are happening in our speciality, there are evolving regulatory requirements, new knowledge about diseases and drugs as well several new/ enhanced IT solutions to support Clinical and Pharmacovigilance functions. Our leaders are well aware of these developments and provide the most current and relevant solutions to the Clients and can deliver effective technical solutions.

Tell us about any challenges you are facing currently

We miss our time together in the office due to the COVID situation’s imposed lockdown. I miss meeting team members, partners, and industry colleagues in person now that we have shifted to a virtual office and meetings to reduce risk.

What is your strategy to reach new industries and new customers?

High quality of work, customized services as per the Client needs and repeat business is our key strategy. CLINEXEL is getting business through recommendations by existing clients. A significant percentage of our business is repeat business. Pharma is small world, and our strategy is to deliver high quality results at efficient costs.

Ecosystem in India is conducive to clinical research. I want to highlight, since the New Drugs & Clinical Trials Regulations (NDCTR) went into effect in 2019, regulatory approval timelines and processes are further streamlined. We have multiple positive experiences with CDSCO office during SEC meetings and other interactions. We have received NOC (CT-06) to conduct first in man clinical trials from the CDSCO office in less than a month time. Company aims to become the partner of choice for mid-size pharma and medical device companies by providing clinical research & medical support.

In Pharmacovigilance, we have a unique model of providing end to end services for small and mid-size pharma along with our safety database partners in a cost-effective manner to achieve pharmacovigilance compliance and success in pharmacovigilance inspections.

Can you give me an example of how the company has a diverse workforce?

The CLINEXEL team has a combined expertise of over 100 years.

Our technical team consists of certified healthcare experts, including MDs and pharmacists, who have extensive clinical and pharmacovigilance experience.

CLINEXEL Team has experience in various therapeutic areas, for examples, oncology, rare disorders, diabetes, respiratory, dermatology and on different therapeutics including new chemical entities, biologicals, and generic drugs. Team includes young professional, as well as experienced staff from diverse backgrounds.

Tell us about the CEO/Founder of the company.

Dr Deepa Arora, the CLINEXEL’s Founder and Director, has over 20 years of expertise in the pharmaceutical sector in Pharmacovigilance and Clinical Research. She has worked in worldwide leadership roles in significant pharma businesses as a physician (MBBS, MD).

Dr Arora is well-versed in the commercial needs of regulated and semi-regulated markets and can help CLINEXEL clients build bespoke, tailor made solutions for Clinical Research and Pharmacovigilance activities.

Tell us something about your achievements and recognitions?

We set-up capabilities and world class systems for Clinical Research and Pharmacovigilance within first year of the set-up. We have built a strong team of experienced and dedicated professionals. Currently, CLINEXEL is working on Phase 1, 2 and 3 Clinical Trials of NCEs, and Pharmacovigilance for regulated and semi- regulated markets. CLINEXEL worked with more than 20 clients in 2 years. Clients engage us for repeat business.

CLINEXEL is ISO certified for Quality Management Systems and Information Security Management Systems. We are also registered with SAMS, USA.

We have been appreciated by our clients for the quality of our work and dedication and commitment of the team. In 2019, CLINEXEL has been awarded “Best Pharmaceutical Scientific Support Provider 2019, India” by Global Health and Pharma, UK under the Category International Life Sciences Awards & in 2020, CLINEXEL won Company of the Year Award in CRO Category by SiliconeIndia.

Financially, Company has been in profit from the first year and we grew almost 3 times (300%) in the second year.

  • Industry : Pharmaceuticals

  • Company size : 11-50 employees

  • Headquarters : Navi Mumbai, Maharashtra

  • Type : Privately Held

  • Founded : 2019