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CEBIS USA Integrated Clinical Trial Platform with Interactive Web Response System (IRT/IWRS), Electronic Data Capture (EDC), and Medical Coding on a single database provided an end-to-end solution for one of the global studies. The study was a Randomized, Double-Blind, Placebo-Controlled of different doses of medication in Subjects with a neurological condition. This long-term study was conducted in 3 different locations (the US, Europe, and India) with one CRO and about 100 sites.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Neurology Study
Sample Size: 800+
CROs: 1
Submission: FDA
Phase: Phase 2
No of Sites: ~100 Sites
Warehouses: 3 (US, Europe, India)
SOLUTION IMPLEMENTED
I Clinical Trial Platform
MRS+ EDC + Medical Coding
Site Management
IP Management
Subject Management
Data Management
Medical Coding
Subject Safety
Our Unified System provided a centralized platform for the complete study data management for a sample size of more than 800. Stratified Biomarker Analysis based on the group was also implemented by SyMetric CTP for this study.
KEY CHALLENGES ADDRESSED BY OUR PLATFORM IN THIS STUDY
Releasing the Protocol Amendments to individual Sites in a targeted manner based on their respective IRB Approvals, ensuring system availability to the other Sites with absolutely no downtime.
Ability to run multiple Study Versions simultaneously on the same Study.
CEBIS’s Interactive Web Response System (IRT/IWRS) Module was implemented for one of the U.S.-based multi-centric, randomized controlled Respiratory studies that included more than 100 sites spread across the state.
Our platform was used to screen more than 3500 subjects with only a short recruitment period of 12 months. Our IRT/IWRS System provided a centralized platform for a single CRO to monitor the IP supplies across the Sites spread all over the U.S. and track Shipment Requests in real-time to ensure adequate quantities for randomized Subjects.
Our platform also provided Central Safety access to the Pharmacovigilance Team operating from a different country to assess the treatment and ensure drug safety.
Multi-centered, Randomized controlled, U.S. Based Study.
Sample Size: 3500+ Screened
CROs: 1
Submission: FDA
Phase: Phase 3
No. of Sites: 100 + Sites
Warehouses: 1
SOLUTION IMPLEMENTED
Clinical Trial Platform
MRS
• Site Management
• IP Management
• Subject Management
• Subject Safety
Key Challenges Addressed by Our Platform:
Centralized Platform for the CRO to track and monitor the recruitment and drop-out rates across 100+ Sites in real-time.
Allowed the CRO to monitor the IP supplies across the Sites spread all over the US and track Shipment Requests in real-time to ensure adequate quantities to meet the short recruitment period of 12 Months for randomized Subjects.
CEBIS’s Interactive Web Response System (IRT/IWRS) Module was implemented for one of the global studies sponsored by a U.S. pharmaceutical company. The study was a multi-centric, placebo-controlled, randomized parallel-group study to compare the therapeutic equivalence of medication in subjects with respect to Gastroenterology. It was conducted in seven different countries with three different C.R.O.s located in the Americas and India; one at each site individually looking into the database restricted to their location.
Our IRT/IWRS System provided a centralized platform for the Sponsor to monitor the recruitment rates and maintain complete accountability of IP Stocks at Sites for a sample of more than 500, spread across 50+ Sites, 2 Warehouses – Central and local warehouses in 2 different continents, multiple C.R.O.s, and the Sponsor.
Multi-centric, Placebo controlled, Randomized parallel group Study.
Samble Size: 500+
CROs: 3 (Americas and India)
Submission: FDA
Phase: Phase 3
No. of Sites: 50+ Sites
Warehouses: 2 (1 Central, 1 Local)
SOLUTION IMPLEMENTED
Clinical Trial Platform
MRS
• Site Management
• IP Management
• Subject Management
Key Challenges Addressed by Our Platform:
✓ Provided a centralized platform for the Sponsor to monitor the Recruitment Rates and IP Stocks at Sites spread across 7 countries.
✓ Managed Data boundaries between 3 CROs who were monitoring the individual regions and the respective Sites within that region.
✓ Unified platform for sharing relevant Study Information between 30 Sites, 2 Independent Warehouses, 3 Independent CROs, and the Sponsor.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum information you can provide.
