International Life Sciences Awards 2023

30 GHP International Life Sciences Awards 2023 As a clinical research organisation, CLINEXEL Life Sciences (CLINEXEL) provides end-to-end services in clinical development, clinical operations, medical writing, and pharmacovigilance. We dive into the company and its services as it is recognised in the International Life Sciences Awards 2023. Best Full-Service CRO Clinical Trials Organisation 2023 - South Asia ith a mission to serve patients, CLINEXEL works with pharma and biotech companies that are developing innovative therapies and diagnostics. By supporting these companies to accelerate their clinical development and marketing approvals of their new medicines and diagnostics, it can reduce patients waiting times to access the treatment they need. CLINEXEL specialises in clinical development and safety monitoring of products for global development and marketing authorisation. Its services include the development of robust clinical and regulatory strategies, regulatory consultations/ scientific advice/pre-IND meetings, negotiating optimised plans, and preparation of protocols for clinical study report writing. Clients can access a team of experts to help them organise and plan their clinical programs efficiently. With endless paperwork to work through, regulations to meet, and a product to perfect, a little help goes a long way, especially with the setbacks you may encounter. CLINEXEL has a strong track record of negotiating with regulators at different stages of product development, so its services are incredibly valuable as it assists with preparing the documentation of regulatory approvals. As a member of the Association of International CROs, ( AICROS) CLINEXEL can conduct clinical trials in all major geographies. Clients across the world can benefit from its ability to do highquality trials at an optimised cost by using a variety of efficiency approaches. Its trial management activities include global project management, site selection, site monitoring and data management services, as well as identification. “We can provide time and cost-efficient services, helping companies expedite the clinical development of their products by a first-timeright approach.” Some of the biggest challenges that the clinical research industry faces include evolving regulations, delays in the study start-up, patient recruitment, and unexpected increase in the trial budget. On top of this, regulatory and standard of care are not the same across the geographies, which adds to the complexity of the process. These potential challenges that clients go up against are a lot more manageable with CLINEXEL’s expertise. The team at CLINEXEL includes physicians and pharmacists who have medical knowledge of the pathophysiology and natural history of the disease and are experienced in clinical development and standard of care. Therefore, it can advise efficient study designs with clinical endpoints that comply with regulations and as a result, clients’ products are accepted. CLINEXEL’s Director, Dr Deepa shares, “We have strong regulatory intelligence, due to which our experts are well versed with the latest developments in the concerned therapeutic areas, we have an extensive network of KOLs where we have first-hand experience of conducting the clinical trials, thus ensuring a predictable patient recruitment rate and high-quality data for the clinical trials managed by CLINEXEL.” In an industry that is constantly changing, CLINEXEL follows the latest trends in regulatory thinking and approaches for granting new approvals to better support clients in their product development journey. By staying on top of the shifts taking place, it adapts its approaches to provide clients with productive services that consider the risks at play. When working on a project, it asses the challenges that may arise and puts together efficient risk management strategies that help clients overcome and succeed in their endeavours. CLINEXEL has been able to support small biotech companies to start effectively, saving them years of delays and significant amounts of money through its designs and executions of trials. We are delighted to share that this has led CLINEXEL to hold the title of Best Full-Service CRO Clinical Trials Organisation 2023 - South Asia. If you are trying to bring a product forward that could benefit thousands of patients worldwide, get in contact to access the help that will accelerate your product development process, saving you money in the long run. Take advantage of its expertise now and see for yourself what it can help you achieve. Contact: Deepa Arora Company: CLINEXEL Life Sciences Pvt Ltd Web Address: W May23572