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IT Focus Approach

Introduction:

DCRC is determined to make the most of Information Technology to improve the Pharmaceutical and Biotechnological industry, with excellent planning and resources. This ensures your clinical studies yield high quality data within strict timelines and budget requirements.

At DCRC, we are proud to provide support for your clinical research needs from a basic web interface to the most sophisticated analytical tools, and we do it at very competitive prices; we also support most of the leading EDC Products available in the market. Our IT Department consists of highly skilled and motivated individuals who have extensive experience in IT products and services. Our team has been successfully involved in several EDC related projects in the USA. We ensure that all medical services meet the guidelines of good clinical practice and the latest FDA/EMEA requirements.

Our major strength is in developing computer-based tools for:

• EDC (Electronic Data Capturing)
• Bio-statistics
• Health outcome
• Clinical Trials Simulation
• Pharmaco-Economics
• Six sigma processes

We have capabilities in implementing Clinical EDC solutions. Our team is well experienced on these tools and has work experience to achieve your EDC implementation goals within specified timeframe. We have solid Project Management capabilities to ensure that deliveries happen on time with the highest data standards.

EDC (Electronic Data Capturing):

EDC was first started in 1998, ever since it is being used by many clinical research companies.  EDC captures data electronically so it helps us get the information fast, and it offers great potential for improving the clinical development process and bringing products to market much faster when compared to the manual paper based data management.

Advantages of EDC:

• Online data collection
• Monitoring and processing through internet connectivity to a secure central database.
• New devices like PDA and tablet computers can be used.
• We can generate data while testing and while data is being collected.
• Easy access from anywhere without having to sacrifice the patient security and privacy.
• Accurate and reliable data.
• Reduces the drug cost by streamlining development functions.
• Products reach the market sooner.
• Electronic submission enables pharmaceutical companies to speed up approval process.
• Redundancy is eliminated and errors are avoided.
• Interactive voice response which is being used for almost a decade now will have an enhanced version.
• Analysis and reports of clinical trials could be accessible by physicians and researchers in no time.
• Electronic submission enables pharmaceutical companies to speed up approval process.
• Redundancy is eliminated and errors are avoided.
• Interactive voice response which is being used for almost a decade now will have an enhanced version.
• Analysis and reports of clinical trials could be accessible by physicians and researchers in no time.

What we offer:

We can provide our expertise in the following EDC implementation areas Electronic Data Capture:

• Feasibility Analysis of implementing EDC.
• Study/ Site data collection methodology.
• 21 CFR 11 requirements analysis.
• Preparation of Data Management Plan.
• EDC Tool selection.
• Interface design for integration with external data sources (including Hybrid approaches).
• EDC Screen Design.
• Edit Check identification.
• Data Security implementation.
• Data Interoperability using Operational Data Model (CDISC-ODM).
• DBA services.
• DCF and Query closure.
• Patient Diary integration.
• Adverse Event data integration.
• Build EDC Database.
• Simulate actual EDC data entry using Simulation mode.
• Project Management.
• Quality Management.

Key Features:

• Simple interface allows easy configuration of eCRFs, workflows, security access, edits patient’s / subject’s data.
• Real time access through any internet enabled computer enables team collaboration
• Studies deployed with a press of logon button.
• Global Library stores forms and their components for secure re-use.
• Architect loader transforms full study specifications to offline format for easy review, archiving or study movement.

How we work:

Capturing Clinical Data:

• Web enabled interface available from any computer in the globe.
• No software to install or maintain at the clinical site.
• Advanced tools for entering and monitoring the data.
• Configurable security based on role and workflow.
• Designed to comply with regulations around the world.
• Edit checks run in real time and immediate resolution includes cross visit and cross panel checks.
• Configurable workflow fits customer’s organization.
• All levels of users trained quickly and efficiently.
• Electronic signature support compliant with 21 CFR parts 11.

Clinical Data Management:

• Single server system for EDC and CDMS.
• Rich and advanced management tools.
• Full query management team.
• Flagging and classification of protocol deviations.
• Multiple configurable levels of data review and data locking.
• Individualized task list visible at log in and automatically updated.
• Source document verification integrated with data management
• Efficient handling of both central and local centers.

 Reporting Clinical Data:

• Reporting accessible through web enabled interface
• Security insured by restrictions based on user assigned roles and responsibilities.
• Standard reports for study metrics and clinical data lists
• Versatile custom report creations
• Customizable report parameters and parameter validation
• User driven report creation
• Real time clinical reporting with reviews
• Sophisticated reporting and analytics with business objects
• Direct access for analysis.