MakroCare announces the completion of Oracle Clinical implementation to strengthen its Clinical Data Management services. This implementation will help the company in creating a faster data management solution, which improves time lines and optimizes the cost of the clinical trial.
MakroCare has top of the line infrastructure to help life sciences companies to conduct the global trials. Some of them include Oracle Clinical (version 4.5.2), Oracle Thesaurus Management System, MedDRA (Version 10) dictionary, mCTMS and SAS. Oracle Clinical is a comprehensive clinical data management solution which allows companies to standardize and control data definitions and data usage across the global operation, ensuring that data is defined, managed, and interpreted consistently worldwide. To ensure that our data management capabilities meet stringent quality standards, we validate our clinical databases and software in compliance with the regulatory bodies and 21 CFR part 11 environments. MakroCare is the first to receive ISO 27001 certification for information security. The company has been awarded ISO 9001 for Data management security system and several other protective measures.
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, project and data management, clinical monitoring, quality assurance, medical writing, PMS/PharmacoVigilance, biometrics, and regulatory assistance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania) and India (Hyderabad).
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