Your Trusted Partner For Clinical Research and Pharmacovigilance

GLOBAL CLINICAL DEVELOPMENT

At CLINEXEL, we are providing global clinic-regulatory services to companies for the development of their new chemical entities and biologicals. We have supported companies for pre-IND and scientific advice meetings for firming up their clinical development plans and regulatory strategies. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals.

WE SUPPORT COMPANIES BY

Development of efficient clinical development plans acceptable to different regulatory authorities
Facilitating pre-IND, End of Phase and pre-NDA submission meetings with regulators to develop and fine tune clinical development plan
Filing and maintaining IND in US, clinical trial applications in EU and IndiaGlobal solutions for CLINEXEL clients through world-wide clinical trials

CLINEXEL IS A MEMBER OF ASSOCIATION OF INTERNATIONAL CLINICAL RESEARCH ORGANIZATIONS OR AICROS (WWW.AICROS.COM)

AICROS is an official network of small and mid-size CROs, with a proven track record of providing high quality clinical research services to pharma industry. As an alliance of local and well established CROs, we combine our strengths and know-how to accomplish the clinical development goals of our clients. AICROS success is based on several years of experience of working together in conducting phase I to IV clinical trials, non-interventional studies and clinical investigation of medical devices all over the world.

HOW DOES IT WORK ?

For a global clinical trial, clients are provided options of various countries where AICROS members are present with details about regulatory requirements and clinical trial approval timelines, medical practices, experience of trial sites and local CRO in the therapeutic area and recruitment projections, with costing. One of the AICROS members will take up the project management and other CROs will provide local regulatory, site selection, monitoring, study management services and will facilitate in the logistics of import of IP and clinical trial supplies and export of samples to central lab.

Activities like medical writing, medical and safety monitoring, data management, statistical analysis as well as management of subcontracted vendors like central lab, will be centralized and managed by one CRO. Thus, clients will be interacting mainly with Project Management team who in turn will coordinate with local CROs, who are AICROS member CROs.

WHAT ARE THE ADVANTAGES ?

Through AICROS, we are able to provide global coverage in over 80 countries over 4 continents. Thus, having global coverage, extensive cumulative experience, we are able to offer customized solutions to our clients with strong local service providers. We deliver added value for companies who intend to conduct multinational studies in a speedy and flexible manner with the highest quality.