Industry Provider Profiles Company Type Services
Excel Life Sciences (ELS) is a US-based, India-focused provider of comprehensive clinical trial management services. Unlike a traditional CRO, our site-centric model involves placement of a highly trained clinical research coordinator at each study site, dedicated to your study. This approach is proving successful to our clients, who are rewarding us with nearly 100% repeat business. Specifically, our metrics tell the story:
Start-up: Enrollment of first patient within 6 weeks of regulatory approval & 14 days of SIVEnrollment: Enrollment of +2,000 patients on time or ahead of scheduleRetention: 95% average patient retention vs. 75% industry averageCompliance: Of nearly 30,000 patient visits, less than 0.5% was missedCompliance: Sites managed by ELS have undergone successful USFDA and EMA auditsData Quality: In recent global trials, our sites had 80% fewer queries than all sites globally
Basic Facts about Excel Life Sciences:
350 clinical trials conducted
+50 years of combined regulatory expertise
135 IND approvals
20 NDA approvals
Trained over 1500 clinical research personnel in India
Presentations at more than 175 conferences
Published more than 50 times in industry trade journals and magazines
Why Choose Excel Life Sciences
Highly flexible and nimble organization, unlike large CROs
Proven track record of supporting small to mid-size trial sponsors
Operations team with extensive multi-national trial experience
True localized India expertise and capabilities = Savings
Performance based budgeting:
Fixed price budget
Significant payments tied to performance milestones
History of no change orders unless significant scope increase
Operating model in India: CRC at each, dedicated to your study
A-Team today, A-Team through study close-out
Excel Life Sciences has a suite of solutions designed to meet the needs of studies large and small and across a broad spectrum of therapeutic areas. Our model involves placement of highly trained clinical research coordinators at each study site, supported by a strong project management team from our offices in Delhi and Kolkata. ELS study coordinators have extensive training on ICH-GCP, India-GCP and soft skills training. This support system takes the burden off of the investigator at these sites, which is critical because of the volume of patients they see and the significant number of new investigators involved in clinical research in India.
Our comprehensive site support model includes the following:
Study Feasibility Analysis
Site Selection
Regulatory and ethics committee document submissions
Set up of the research site
Patient Screening and Enrollment
Schedule follow up visits
Maintain and dispense drug and other study supplies
Timely and accurate CRF transcription
Ensure GCP adherence and compliance
Data entry and data management as per global regulatory and audit standards
Prepare site for audit visits and respond quickly to any queries
Avoid time and cost overruns
Convert excellent clinicians to successful investigators
ELS specializes in the following therapeutic area. Please visit our website for detailed information about our experience, investigator network and patient demographics:
Ophthalmology
Endocrinology
Cardiology/Vascular
Oncology
Neurology
Dermatology
Gastroenterology
Infectious Disease
Internal Medicine
Nephrology
Orthopedics
Pediatrics
Psychiatry
Respiratory Diseases
Vaccines
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
Over 1,300 investigators
Over 150 data points are collected and evaluated for each site
Sites specializing in more than 14 therapeutic areas
Each site is supported by a full-time ELS study coordinator
ELS clinical operations team has managed investigative sites that have undergone successful US FDA and EMEA inspections
Excel Life Sciences is a multi-national company with offices in three U.S. cities and operations in 24 cities across India. Specifically, Excel Life Sciences has offices in the following cities:United States Headquarters: Other Locations:
Research Triangle Park, NC
Boston, MA
India:
New Delhi (India HQ)
Kolkata
ELS also has partners with offices in Switzerland and Israel.
Dan McDonaldsolutions@excellifesciences.com
Saurendra Das MDContact Company
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