While Infoclin consultancy has developed one of the largest networks of investigators and investigative sites, it’s important to understand that we select and accept only the most qualified people and organizations into that network. These investigators and sites undergo a rigorous review process that includes examination of over 150 different data points and each is expected to exceed in three critical areas:
The study feasibility is an integral and critical initial step in the conduct of any clinical trial. IFL facilitates this initial step by a well organized, systematic and detailed process. The presence of IFL Clinical Research Coordinators in every city ensures that the data collection is real time and factual.
The feasibility process includes the following: Initial receipt of study synopsis from the client
As the number of clinical trials conducted in India continues to increase at a rapid pace, so does the need for qualified investigators and site staff to conduct those studies. While India has one of the worlds largest and most experienced physician populations with over 100 physicians across the country, the number of clinical research-experienced and GCP-trained clinical investigators are still low. Also, these physicians typically have very large daily patient loads and lack the free time to run a clinical study effectively without assistance. Compounding the issue even further, IFL research has found that less than 10% of all investigative sites in India have a full time clinical research coordinator on staff.
Site Management Services from Inoclin help take the burden off of investigators so that they can focus on the patient, and ensure that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for regulatory and product approval submissions.
Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The coordinators at our site managment organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.
The regulatory landscape in India is complex and dynamic. Over the last few years alone, there have been huge changes that have occurred in local and national regulations related to the conduct of clinical trials. Navigating this landscape can be challenging without understanding the guidelines and laws, having the mechanism to track, anticipate or react to changes and having the credibility and track record necessary to resolve issues quickly. IFL offers you industry-leading regulatory expertise to be your trusted partner in navigating the regulatory process, allowing you to move the development process forward efficiently and without glitches.
From comprehensive regulatory and trial management support for your important study, to simply consulting you on the regulatory environment, IFL can make your foray into India easier, giving you the confidence to move decisively when you are ready. Specifically, IFL can assist you with the following activities:
Site Management Services from Infoclin help take the burden off investigators planning to do clinical trials in India so that they can focus on the patient, and ensure that the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for regulatory and product approval submissions.
Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The coordinators at our site management organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.
Clean, high-quality data is one of the most critical elements of any clinical trial. Therefore, site management is a core service of Infoclinand a critical part of our overall customer value proposition. Between the full-time dedicated clinical research coordinator we place at the site and our highly skilled project and site management personnel; we ensure that the data coming out of the investigative sites for your study is the highest quality possible. We have the experience, bandwidth and technology necessary for on-time database lock for any study that we take on and the commitment to make it happen.
Given the dynamic nature of the clinical research industry, training for both new and experienced clinical research professionals is a critical component of any drug development program. This is especially important in India because of the relatively young age of the industry. Infoclin believes strongly in ongoing training and education, both internally, with our own team of clinical research professionals, and externally with our clients and partners. Our team of instructors has industry leading hands-on clinical trials experience and has trained over 1,500 clinical research professionals, including physicians, executives, CRCs, CRAs and nearly all other stakeholders in the clinical research process. In addition, our instructors are frequent visiting professors at some of India’s top academic institutions for clinical research. Whether it’s at our state-of-the-art training facility in New Delhi, in a hotel conference room or at your offices, we can adapt our programs to meet the needs of groups large and small.
All IFL team members assigned to a project are trained and well versed in ICH-GCP and other Indian and global regulatory guidelines. Each operations team members is trained at regular intervals during the course of the trial.
IFL team also imparts ICH-GCP and other regulatory to all stakeholders. IFL has trained more than 500 research professionals Investigators and site team:
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