Electronic Data Capture

688 views

Published on

MakroCare’s new pharma informatics service –mEDC, is a web-based technology for managing single or multi-site clinical research studies with complete audit trail.

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
688
On SlideShare
0
From Embeds
0
Number of Embeds
3
Actions
Shares
0
Downloads
17
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Electronic Data Capture

  1. 1. USA  EUROPE  ASIA www.makrocare.com/ddi A TOP 20 client has multiple clinical studies in clinical research and late phase. Because of global competition and safety concerns, need for ongoing patient data for marketed products is increasing daily.  These reasons prompted this client to take up more late phase activity. As the budgets were fixed, client had a challenge to conduct more studies within limited budget. One of the common components was electronic data capture. Client was using a global EDC product for PMS and other late phase studies. As the cost of ownership and support was high for this product, client started exploring alternate validated EDC products that can have similar functionality but at very low cost. Challenge As mEDC is web based and easy to deploy, MakroCare was able to do study startup and deploy the database for FPFI in 3 weeks from the finalization of the CRF. Client realized the aggressive timelines they had and a cost savings of over 50% on the EDC infrastructure. Very satisfied with these results, client awarded MakroCare all late phase studies integrated data management (mEDC, study setup and CDM) work. Outcome About MakroCare MakroCare is a global drug development services firm that operates through 4 main divisions - CRO, SMO, Informatics and Consulting. Integrated and innovative services in the areas of regulatory affairs, risk management, site management, patient recruitment, trial management (P II/III and late phase), biometrics, qa audits, PV/Safety, and informatics. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania, California), Japan(Tokyo), India (Hyderabad, New Delhi, Mumbai, Bengaluru), Singapore, and Europe (Frankfurt, Paris, Basel). MakroCare, with its informatics division DDi, was able to provide a feature rich and cost effective solution by implementing mEDC to the client for all the late phase activity. mEDC is completely validated and simple to do study setup. Client liked the features of mEDC and termed as “Right Fit” for PMS studies as these studies doesn’t need too many features and hence client wanted to pay for only what they wanted. Since the output for this tool was in different formats (Excel, SAS, CDISC), statistics and medical writing teams also had an ease in adapting mEDC. Solution

×