EDC build, support, and mid-study changes


EDC BUILD

INDEGENE'S EDC STUDY BUILDERS POSSESS A UNIQUE COMBINATION OF TECHNOLOGY EXPERTISE, A DEEP UNDERSTANDING OF CLINICAL RESEARCH, AND RICH INDUSTRY EXPERIENCE. WE HAVE HELPED MANY SPONSORS WITH THEIR BIOTECHNOLOGY, PHARMACEUTICAL, AND MEDICAL DEVICE STUDIES, DELIVERING OPTIMIZED TRIAL DESIGNS FOR YEARS. IN FACT, WE'RE KNOWN FOR FINDING THE BEST SOLUTIONS AND MOST EFFECTIVE METHODS, OFTEN INCORPORATING INNOVATIVE TECHNOLOGIES TAILORED TO EACH OF OUR CLIENT'S NEEDS.

The Indegene study build team is nimble and responds rapidly to client needs. Our skilled database development team begins with a careful evaluation of your individual study or clinical program to propose and build a robust, cost-effective, secure, and compliant database solution to meet your specific requirements. We then identify a core team, which typically consists of a Project Manager, Lead Data Manager, and Lead Programmer, all of whom stay on the project from start to end.

Indegene applications and Electronic Data Capture (EDC) Vendor partner applications are 21 CFR part 11-compliant. We provide EDC study build for complex clinical trials across therapeutic areas including oncology, infectious disease, immunology, cardiovascular, and many others.

 

Indegene's study builders and edit check programmers work around the clock to ensure we deliver your database on time and within budget. We understand that building high-quality databases can reduce your overall study costs.

Indegene provides services in EDC systems as chosen by the client. Indegene's team has an expertise with several EDC systems, including:

  • Medidata (CRO Partner & Rave Accredited)

  • Medrio (CRO Partner)

  • Merge eClinicalOS (CRO Partner)

  • Oracle Inform

Indegene's database build process follows Agile methodology with QC at every level from our dedicated QC team. We perform standard data transfers using SAS OnDemand and custom data transfers with required QC, based on client requirements. Indegene is happy to work with your standard CRFs and build designs, or use the Indegene CDASH-based library of Standard Templates.

 

 

EDC Support
 

Indegene provides the following EDC support services:

  • Medidata Rave User and Site Administration

  • SAS OnDemand

  • PDF Generation

Mid-Study Changes

 

Mid-study changes happen in almost all studies due to amendments in protocols and with multiple changes to the study for each amendment. Protocols are getting more complex, CRFs are getting larger, and trials are lasting longer and are global in nature. In short, the ability to handle the mid-study changes is critical to the success of a trial.

These changes can create delays, add cost, and increase risk due to the following factors:

  • Change Management

  • Deployment Challenges

  • Data Migration

  • Multi-system Impact

A combination of expertise, technology that can support real-world change, and a process-oriented approach is required to effectively deal with the changes.

We have the strongest team in the industry that supports hundreds of migrations each year for our various customers.