Consulting Solutions
The Clinical Research industry of India is witnessing some very important changes in the regulatory standards for Clinical Research with some significant changes such as:
Release of 3 gazette notification Rule 122 DAB,Rule 122DAC and Rule 122DD in January 2013 and February 2013.
Inspections of Ethics Committees & Investigator sites.
Posibility of registration of sites & black-listing of investigators.
CDSCO has instucted the zonal offices of CDSCO to keep records of names,qulification of investigators and clinical trial sites and constitute Expert Committees to conduct clinical trail inspections.
The sites shall be visited by these Expert Committee members atleast once a year.

In view of all these changes,only those sites and Ethics Committes which maintain high standards of quality and ethics shall survive in the Clinical Research industry.

SenseCR's Consulting Solutions supports the sites and Ethics Committes in getting that edge over others.

Consulting for Research Naive Sites:

The biggest challenge for a research naive site is to develop the site in compliance with all regulatory and GCP standards, such that a Sponsor / CRO feels at ease in conducting trials with the site, inspite of it's "Research Naive" status. We help the new sites to set all their processes in compliance with the applicable regulations and guidelines, and in ease with the site's general practice.

THIS INCLUDES :
Consulting for Experienced Clinical Research Sites:
With the stringent requirements set forth by the regulatory authorities for conduct of Clinical Research in India, it has become paramount for even experienced Research Sites to have a re – look at their Processes, Documents& SOPs for Clinical Research and ensure that the same are in line with the current regulatory and compliance requirements. An experienced external party like SenseCR can be valuable in helping such sites to achieve this.
We provide the following consulting solutions for experienced Clinical Research sites:
Compliance visit to the site
Based on the observations of the compliance visit, assisting the site in developing the Corrective And Preventive Action plan (CAPA)
Assisting the site in implementing the CAPA
Fulfilling the training needs of the site
Review of existing SOPs and aligning them to current requirements/standards
Plan for on-going, continuous monitoring
Assisting the site in preparing for Audits & Regulatory Inspections
Promoting the site by recommending it to our network of various Sponsors and CROs
CONSULTING FOR ETHIC COMMITTEES:
We assist the Ethics Committees by providing the following consulting services:
For Ethics Committee members
Based on the observations
of the compliance visit,
assisting the Ethics Committee in developing the Corrective And Preventive Action plan (CAPA).
Ethics Committee SOP review
& alignment to regulatory &
GCP requirements
Plan for on-going, continuous monitoring
Of Ethics Committee
Assisting the Ethics Comm
ittee in preparing for Audits
& Regulatory Inspections
For Ethics Committees which have not yet been registered with Licensing Authority, we consult the Ethics Committee in Dossier preparation for submission to licensing authority.
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