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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.
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.
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.