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Clinexa is a CRO that is a class apart! We believe that the best value a CRO can offer is through complimenting the Sponsor and/or another partner CRO in providing a platform for seamless project management both in-house & at the investigative sites. The following characteristics about Clinexa differentiate us as a CRO partner that you can fully trust your study with.

Clinexa has enhanced control over study management as a full service CRO – from protocol to study report. We provide in-house project management, clinical operations, clinical data management, biostatistics, medical writing, regulatory consulting, site management services, post-marketing surveillance, peri-approval and rescue studies, amongst others. All staff members including CRAs and CRCs are trained on GCP and other clinical research aspects using cutting edge technology of the James Lind Institute (JLI). JLI is a fully owned educational division of Clinexa Life Sciences.

For Site Management Services:

Clinexa has its own well trained and constantly expanding CRC pool. CRCs are deployed at the investigative sites based upon their demographics, prior experience with the same site, same therapeutic area, same sponsor, etc. The CRCs go through a training curriculum that equips them to efficiently support the study at the investigative site. Adequate back-up CRCs are available when the need arises. Contingency plans are created at study start up so risk due to a CRC becoming unavailable at a short notice can be mitigated.

Clinexa designates a project manager for each study. The CRCs involved in a particular study report directly to the project manager. The project manager is an active link between the investigative site and the CRO/Sponsor. The Project Manager makes sure that the CRCs are executing the day to day tasks as expected by CRO/Sponsor and queries are resolved with minimum delays. The project manager also makes sure that the study is conducted at the investigative site with the highest quality and ethical standards. A communication plan is developed by the project manager at study start up and shared with the CRO/Sponsor. Clinexa CRCs and Project Manager make sure that the CRAs effort and time utilization at the site is highly efficient.

We develop our investigator network on the guidelines of the NIH-Roadmap of Medical Research for a better translation of scientific discovery into clinical practice. We see clinical research as a vital sector of translational medicine and a bottle neck of drug discovery which needs the re-engineering measures for an efficient outcome. Our inventory of network investigators belong to a whole spectrum of therapeutic areas which have the capability of investigating the blockbuster drugs as well as the nichebuster drugs developed as personalized therapies in the evolving theragnostic model.

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