Case Studies
KNOWLEDGE CENTER

A Simple Innovative Modification in the PharmacoVigilance Process Shows Great Improvement in Data Accuracy

A Simple Innovative Modification in the PharmacoVigilance Process Shows Great Improvement in Data Accuracy

PDF Read More


QUALITY ASSURANCE STRATEGY

Introduction: The Clinical Quality Assurance has witnessed a dramatic rise in its impact and effectiveness in the drug development and clinical research. The first applications of quality assurance to the drug development , pre-clinical studies , and clinical research have been explored from the day of its infancy ,by a handful of drug pioneers. Quality assurance has been integrated with all the phases of clinical research and drug development.

PDF
Read More


Practical Knowledge of Regulatory Guidelines for E-Drug Marketing Applications Makes for Smooth Submissions.

One of our clients wanted to submit electronic Abbreviated New Drug Application (ANDA) to USA FDA, to get market approval for a generic drug. We prepared the entire ANDA in electronic Common Technical Document (eCTD) XML format.

PDF Read More



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.

PDF Read More


Oncology

Indication: NSCLC (Non Small Cell Lung Cancer)

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

PDF
Read More


Have Questions? Need Info/Quotes?

CAPTCHA