The Clinical Research Organization (CRO) landscape is witnessing a dynamic growth fueled by ever increasing outsourcing needs of pharma companies for cost efficiency and specialized expertise. With clinical trials landscape becoming global, competitive and complex; competent CROs are crucial in addressing patient recruitment and regulatory compliance for big and small pharma.

CLINEXEL was borne out of a shared vision of pharma clinical leaders to support the clinical development in unmet medical needs and solve the clinical development challenges, like complex trial designs, problems with recruiting patients, and data management. Experience and expertise of the firm in using various tools of risk minimization with levers of cost optimization and efficiencies have been useful for multiple clinical candidates developed by biotech companies.

CLINEXEL One of the top CROs in India and Asia, CLINEXEL is providing global full-service clinical solutions for pharmaceutical and medical device companies worldwide. It ensures its clients achieve efficient and high quality clinical research outcomes by navigating regulatory landscapes globally and optimizing trial strategies.

The company through its mission and services, addresses a significant market niche for independent science based CROs to facilitate the clinical development of innovative products. Through project management, clinical operations, regulatory affairs, and other relevant skills, the company has positioned itself as an accountable partner for firms willing to navigate the

complexities of clinical trials. From day one until now, the company has established a solid presence in India, Europe, Asia and the USA, through alliances. It offers clinical development, clinical trial, regulatory and pharmacovigilance services tailored to meet unique client needs. “Our growth trajectory has been marked by a steady rise in revenue, propelled by a high rate of client retention and alliances facilitated by glowing recommendations and referrals”, says Dr. Deepa Arora, CEO of CLINEXEL.

Empowering Innovation in Clinical Trials

CLINEXEL provides full spectrum of clinical development services, including clinical strategy, project management, clinical operations, monitoring, medical writing, regulatory affairs, clinical data manage-ment, statistics and pharmacovigilance among others. By utilizing strategic alliances and partnerships with other key players in the market, it delivers cost-effective implementation of clinical research activities while maintaining transparency, accountability, and compliance with relevant regulations. The company has been providing full trial solutions as well as customized, client specific functional services as per client needs.

The company stands out as a CRO primarily due to the strong scientific and drug development experience of its leaders, stable leadership with extensive experience in clinical research and drug development. With a team comprising of experienced and qualified professionals, PhDs, physicians, pharmacologists and pharmacists well-versed with medical practice and clinical development, it offers high quality expertise in global clinical trial management. Particularly noteworthy is its role in supporting small biotech and start-up companies with innovative therapies, where its experts guide and draft clinical development plans, regulatory strategies, and efficient trial designs. CLINEXEL has excellent track record in regulatory interactions and negotiations with US FDA, European and Indian regulatory agencies, providing seamless support from preIND meetings to clinical study management.

In global clinical development, CLINEXEL’s collaboration within AICROS alliance offers a unique advantage, enabling access to diverse patient populations and regulatory expertise across multiple countries. Through centralized services and strategic partnerships, the firm effectively competes with larger CROs, delivering tailored solutions with a global reach. In 2023, the company was awarded the Best Full-Service CRO in South Asia by GHP (UK).

In the future, CLINEXEL aims to expand its service offerings and clientele while maintaining a focus on its core values and principles. This involves scaling up services, developing networks of sites and collabo-rations, and leveraging strengths in scientific expertise, regulatory knowledge, and technology. The company anticipates continued involvement in innovative therapies and executing more complex clinical trials to drive further growth and success.