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C A S E S T U D Y
C L I N I C A L D A T A M A N A G E M E N T
Time & Cost Effective Management of Voluminous Clinical
Data is Easier Than You Think!
MakroCare is the right partner for Pharmaceutical companies performing clinical
trials with its expertise and available resources for managing paper based,
voluminous clinical data running into tens of thousands of pages.
analysis,mainly biostatistical analysis.	
Since the clinical data contained in these
CRFs put together are so humongous,it is
a grueling task to enter and validate them
in a CDMS. Also,time required is huge and
cost involved runs into millions of dollars.
This requires well-trained resources of
adequate size who can start the Clinical
Data Management (CDM) on the fly.
To handle such transitory, voluminous
data pharmaceutical companies prefer to
take assistance from reputed CROs who
have expert personnel readily available.
1
In a large number of clinical trials
conducted for pharmaceutical drugs,
the clinical data collected is entered
in paper Case Report Forms (CRFs).
CRFs typically run into hundreds of
pages, and Phase II and III trials would
typically have anywhere between 100-
300 and 1000-3000 patients respectively,
bringing the total to tens of thousands
of CRF pages. This information has to
be entered and validated in a Clinical
Data Management System (CDMS) for
maintaining a repository of validated
clinical data and for retrieval for further
2
MakroCare has a strong CDM team in
USA,India and Germany,who have years
of experience in clinical data management
using Oracle Clinical (OC) CDMS,thereby
providing cost and time effective data
management solution to pharmaceutical
companies. This was a key feature that
our pharmaceutical client in Germany
was looking for from a CRO.
The pharmaceutical client was conducting
Phase II clinical trial in cardiovascular
therapeutic area. The trial was conducted
in three sites with 270 patients in all.
The paper CRFs ran into approximately
140 pages for each patient, totaling the
number of CRF pages to almost 38,000.
The clients were looking at a cost-
effective service from MakroCare; hence
we offered the CDM services from our
offshore site in India. MakroCare designed
eCRFs in OC and performed data entry,
validation and coding of the clinical data
before sending it to the clients.	
Our experience in managing paper
based clinical data using a standard
CDMS, Oracle Clinical, helped the
client to complete the trial in a simpler,
cheaper and faster manner. MakroCare
delivered CDM services that met our
client’s expectations for a cost and time-
effective clinical data management with
the best quality standards maintained in
the pharmaceutical industry.
MakroCare, a global clinical services
firm, provides clinical research support
to pharmaceutical, biotechnology, and
medical device industries. The company
offers site selection, patient recruitment,
clinical monitoring, quality assurance,
medical writing, PMS/Pharmacovigilance,
clinical data management, biostatistics
and regulatory assistance.
MakroCare has offices in USA
(New Jersey, Illinois, Pennsylvania,
California), India (Hyderabad, New
Delhi, Mumbai, Bengaluru), Europe
(Germany-Frankfurt) and Japan (Tokyo).
About MakroCare
Copyright © 2009 by MakroCare. All Rights Reserved.
Visit us at: www.makrocare.com

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Clinical Data Management | Clinical Study Report

  • 1. C A S E S T U D Y C L I N I C A L D A T A M A N A G E M E N T Time & Cost Effective Management of Voluminous Clinical Data is Easier Than You Think! MakroCare is the right partner for Pharmaceutical companies performing clinical trials with its expertise and available resources for managing paper based, voluminous clinical data running into tens of thousands of pages. analysis,mainly biostatistical analysis. Since the clinical data contained in these CRFs put together are so humongous,it is a grueling task to enter and validate them in a CDMS. Also,time required is huge and cost involved runs into millions of dollars. This requires well-trained resources of adequate size who can start the Clinical Data Management (CDM) on the fly. To handle such transitory, voluminous data pharmaceutical companies prefer to take assistance from reputed CROs who have expert personnel readily available. 1 In a large number of clinical trials conducted for pharmaceutical drugs, the clinical data collected is entered in paper Case Report Forms (CRFs). CRFs typically run into hundreds of pages, and Phase II and III trials would typically have anywhere between 100- 300 and 1000-3000 patients respectively, bringing the total to tens of thousands of CRF pages. This information has to be entered and validated in a Clinical Data Management System (CDMS) for maintaining a repository of validated clinical data and for retrieval for further
  • 2. 2 MakroCare has a strong CDM team in USA,India and Germany,who have years of experience in clinical data management using Oracle Clinical (OC) CDMS,thereby providing cost and time effective data management solution to pharmaceutical companies. This was a key feature that our pharmaceutical client in Germany was looking for from a CRO. The pharmaceutical client was conducting Phase II clinical trial in cardiovascular therapeutic area. The trial was conducted in three sites with 270 patients in all. The paper CRFs ran into approximately 140 pages for each patient, totaling the number of CRF pages to almost 38,000. The clients were looking at a cost- effective service from MakroCare; hence we offered the CDM services from our offshore site in India. MakroCare designed eCRFs in OC and performed data entry, validation and coding of the clinical data before sending it to the clients. Our experience in managing paper based clinical data using a standard CDMS, Oracle Clinical, helped the client to complete the trial in a simpler, cheaper and faster manner. MakroCare delivered CDM services that met our client’s expectations for a cost and time- effective clinical data management with the best quality standards maintained in the pharmaceutical industry. MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, clinical monitoring, quality assurance, medical writing, PMS/Pharmacovigilance, clinical data management, biostatistics and regulatory assistance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania, California), India (Hyderabad, New Delhi, Mumbai, Bengaluru), Europe (Germany-Frankfurt) and Japan (Tokyo). About MakroCare Copyright © 2009 by MakroCare. All Rights Reserved. Visit us at: www.makrocare.com