The site, which went live in June, is designed to act as a good clinical practice (GCP) guideline information resource for principal investigators and pharma industry trial sponsors.
As Rao Teki, VP of clinical operations at Makro Care explained that part of the motivation for setting up the site in the first place was the increasing global spread of the trials sector and increasing number of multicentre programmes.
Dr Teki told Outsourcing-pharma that: “There [is] a lack of public site that capture regulations of different countries and answer the GCP queries and questions in different countries.”
He explained the site details all of the latest updates from trial regulatory bodies around the world, as well as all the relevant International Conference on Harmonization good clinical practice (ICH-GCP) guidelines.
“As India is receiving more and more clinical research work year on year basis, the idea behind this… is that India should see and follow ICH-GCP as a legal obligation so as to balance ethical and commercial aspects of clinical research outsourcing work”
He also said that the service is available to investigators working on trials in which Makro Care is not involved, adding that: “the main purpose [was] to make it a public helpdesk so that we can provide answers.”
Makro care told Pharmabiz that “the helpdesk has successfully answered more [than one] hundred queries on various subjects regarding good clinical practices.”
The service can be accessed here .