Case Studies
KNOWLEDGE CENTER

Initiation of a multi-center Phase III clinical study in India within 60 days

Customer Profile : A large MNC pharmaceutical company approached MakroCare to initiate and conduct a multi-center clinical study in India. The study contained a very complex protocol. Earliest initiation of study is the key factor for a successful outcome.

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Oncology

Indication: NSCLC (Non Small Cell Lung Cancer)

A phase III double blind, randomized study in patients with NSCLC

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Optimization of statistical analysis, key to best results!

At times, some clinical data seems insignificant and this might cause loss of highly crucial information and wrong inference about the study. Our statistics team makes sure that such data is not overlooked and is further exploited to yield optimum results.

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A complex oncology clinical study report

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.

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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.

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