Oncology Clinical Study Report | Medical Wiriting1. C A S E S T U D Y
ONCOLOGY CLINICAL STUDY REPORT
A complex oncology clinical study report
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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).