ETHOS CLINICAL RESEARCH

A CUSTOM OF INNOVATION IN CLINICAL RESEARCH

Ethos Clinical Research is a Site Management Organization (SMO) that provides clinical trial related services to Multi centre’s on a contract basis to research organizations, or a clinical site. Ethos Clinical Research will help to get new protocols from Clinical trial vendors of Phase I to IV studies, Instrumentation studies, ICMR based studies, BABE studies etc., and will support with proper consultation and Legal opinion in confirmation of Clinical Trial Agreement with the sponsor.

Our streamlined and integrated site management services are delivered by a dedicated network of professionals with industry and therapeutic area expertise across all phases of clinical development. This, coupled with our in-depth understanding of operations in the ETHOS CLINICAL RESEARCH countries and strong relationships with trial sites, results in beginning of trial and recruitment of patients to achieve our goals.

ethos clinical research site management services include:

Site selection and feasibility

Site contract and budget management

Preparation of site specific documentation

Ethics Committee and Regulatory submissions

Subject recruitment and retention management

Generic and study specific training for clinical trial staff

Coordination of clinical trial medication supplies

Clinical trial monitoring

Assurance of good clinical practice

Site communication strategy and progress reporting

Subject safety management

Third party vendor management

Additional services may be included depending on the client’s needs, providing assistance in preparing sites for clinical trials and ensuring that logistical, regulatory and ethical requirements are met. Such other services may include site Standard Operating Procedure (SOP) writing, arranging for Case Report Form (CRF) development and data management services, organising laboratory sample analyses and document archiving.

Our operational personnel is field based throughout the Indian region, not only to limit travel and support the project team, but primarily to leverage local knowledge of the clinical research and regulatory environments. They focus on developing strong site relationships while ensuring the site’s adherence to data quality, subject safety and early issue resolution throughout the course of the trial.