While Excel Life Sciences 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:
On an ongoing basis, the ELS study coordinators and project management team visit, review and evaluate new clinicians and sites to be added to the network. This due diligence process does not end once a site has been accepted into the network, but instead is ongoing with reevaluation taking place annually and based on dynamic performance records. Below are some facts about the ELS network for your review. ELS helps excellent physicians become successful investigators.
- Over 1,000 research centers and hospitals nationwide
- Nearly 1,350 investigators
- Over 150 data points are collected and evaluated for each site
- ELS investigative sites are located in more than 25 cities across India
- Sites specializing in more than 14 therapeutic areas
- Each site is supported by a full-time ELS study coordinator (when involved in an ELS study)
- ELS clinical operations team has managed investigative sites that have undergone successful US FDA & EMA inspections
The study feasibility is an integral and critical initial step in the conduct of any clinical trial. ELS facilitates this initial step by a well organized, systematic and detailed process. The presence of ELS 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
- ELS internal review for the study specific requirements in terms of the site, type of patient pool, investigator experience and expertise, status of Ethics Committee, site infrastructure and many other parameters
- Shortlisting and matching of study requirements and the sites in the ELS database
- Scheduling appointments with shortlisted sites and investigators
- Personally meet the investigators and discuss the study synopsis, their interest and willingness to take up the study, patient pool, referral activities and other logistics
- Personal meet and/or telecon by ELS managers with investigators for discussions and clarification of queries, if any
- Collate and compile site responses into a Site Feasibility Grid
- Grade and prioritize select sites based upon a number of factors
- Include study specific projections, timelines and Risk Evaluation and Mitigation Strategy
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 600,000 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, ELS 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 Excel Life Sciences 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 more than 25 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. ELS 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, ELS can make your foray into India easier, giving you the confidence to move decisively when you are ready. Specifically, ELS can assist you with the following activities:
National Regulatory Services:
Institutional Ethics Committee services (Sample only – Not a complete list of services or requirements):
- Pre-submission discussions with Drug Controller General of India's Office (DCGI)
- Preparing dossiers for registration of devices and drugs
- Application for permission to conduct clinical trials for New Drug/Investigational New Drug and determine & recommend appropriate strategy
- Interactions with the DCGI office and head to resolve questions and submit amendments
- Obtain import/export licenses for CTM & samples
- Handling of all customs related issues
- Government fees submission
- Study amendment submissions as per D & C Act
- Post regulatory approval compliance
- Protocol with application performa
- Approval of the head of the institution
- Informed consent process (ICF in regional languages)
- Case Report Forms and follow-up cards
- Preclinical animal data, clinical trial data & IB
- Regulatory clearances from DCGI/ other regulatory bodies
- Financial issues related to PI and institutional payments, patient related expenses, etc.
- Agreement to report SAE to IEC
- Assist the PI in completing 1,572
Site Management Services from Excel Life Sciences 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 Excel Life Sciences and 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.
ELS offers the following site management services for clinical research in India:
||During the Trial
- Identify sites
- Identify PIs
- Identify and coordinate translations of Essential documents
- Identify Couriers and other support service vendors
- Regulatory submission & approval with rapid turn-around time
- Obtain import/export licenses for CTM & Samples
- EC submission & approval with rapid turn-around time
- Site set up
- Document collection
- Create source document template
- Prepare site for SIV
- Pre-screening, in case of chronic disease trials
- Assist in the ICF process, screening & enrollment
- Coordinate subject follow up visits preventing lost to follow up & missed visits
- Manage CTM accountability, distribution & logistics
- Coordinate Central Lab logistics & sample flow
- Coordinate Monitoring & Audit visits
- Subject reimbursements
- Maintain and update Trial Master File
- Coordinate SAE reporting on time
- Coordinate close out visit
- Resolve data queries
- Archival at site
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. Excel Life Sciences 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 ELS 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.
ELS team also imparts ICH-GCP and other regulatory to all stakeholders. ELS has trained more than 3,000 research professionals
- Investigators and site team
- Ethics Committee members
- Clinical Research Coordinators
- Clinical Research Associates
- Central Lab team
- Other stakeholders
Whether it’s needing information and advice regarding the regulatory landscape and operating environment in India, identifying partners for manufacturing, formulation development, licensing, or establishing new operations, Excel Life Sciences has the expertise and track-record to help you do it successfully. Our Clinical Trial & Pharmaceutical Consulting services are designed to mould and adjust to your specific needs, while maintaining a focus on practical solutions and cost effectiveness. Built around the expertise of our personnel who offer over 280 years of collective experience, we can help you successfully navigate the dynamic and challenging clinical research environment in India.
Specifically, ELS offers the following customized consulting solutions:
- Understanding & navigating the regulatory and operating landscape
- Identifying pharmaceutical and clinical research-related partners
- Designing and developing SOPs
- Establishing in-country operations
- Technology transfer
- Formulation development (pilot plant scale and commercial scale)
- Customized Solutions based on your needs