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C A S E S T U D Y
ONCOLOGY CLINICAL STUDY REPORT
A complex oncology clinical study report
Visit us at: www.makrocare.com
Copyright © 2009 by MakroCare. All Rights Reserved.
The Customer
	 An international research company with
strong presence in biologics and pharmaceuticals.
The Challenge
	 The client had outsourced the writing of
a complex oncology Clinical Study Report (CSR)
to a medical writing company. The client was
not satisfied with the quality of the CSR draft
as it contained several shortcomings including
misinterpretation of study data and errors in
presentation. Realizing that the study was too
complex for the chosen medical writing team,
the client looked for a reliable partner who could
deliverandapproachedMakroCareforrewritingof
the CSR; MakroCare had successfully completed
several medical writing projects for the client in
the past.
The Solution
	 MakroCare medical writing team took
up the task of rewriting the CSR. The team has
hands-on experience in writing several protocols,
CSRs, and other regulatory documents, besides
experience in writing manuscripts for medical
journals. 	
Thanks to the robust medical writing process
followed at MakroCare that involves drafting
in conjunction with subject experts and
biostatisticians, and a series of critical reviews
including editorial reviews followed by a stringent
quality review, MakroCare delivered a top notch
CSR to client.
CASE STUDY - ONCOLOGY CLINICAL STUDY REPORT
About MakroCare
	 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.
MakroCarehasofficesinUSA(NewJersey,Illinois,
Pennsylvania, California), India (Hyderabad, New
Delhi, Mumbai, Bengaluru), Europe (Germany -
Frankfurt) and Japan (Tokyo).

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Oncology Clinical Study Report | Medical Wiriting

  • 1. C A S E S T U D Y ONCOLOGY CLINICAL STUDY REPORT A complex oncology clinical study report Visit us at: www.makrocare.com Copyright © 2009 by MakroCare. All Rights Reserved. The Customer An international research company with strong presence in biologics and pharmaceuticals. The Challenge The client had outsourced the writing of a complex oncology Clinical Study Report (CSR) to a medical writing company. The client was not satisfied with the quality of the CSR draft as it contained several shortcomings including misinterpretation of study data and errors in presentation. Realizing that the study was too complex for the chosen medical writing team, the client looked for a reliable partner who could deliverandapproachedMakroCareforrewritingof the CSR; MakroCare had successfully completed several medical writing projects for the client in the past. The Solution MakroCare medical writing team took up the task of rewriting the CSR. The team has hands-on experience in writing several protocols, CSRs, and other regulatory documents, besides experience in writing manuscripts for medical journals. Thanks to the robust medical writing process followed at MakroCare that involves drafting in conjunction with subject experts and biostatisticians, and a series of critical reviews including editorial reviews followed by a stringent quality review, MakroCare delivered a top notch CSR to client. CASE STUDY - ONCOLOGY CLINICAL STUDY REPORT About MakroCare 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. MakroCarehasofficesinUSA(NewJersey,Illinois, Pennsylvania, California), India (Hyderabad, New Delhi, Mumbai, Bengaluru), Europe (Germany - Frankfurt) and Japan (Tokyo).