However, the reconciliation process is littered with roadblocks, delays, sometimes misunderstandings, and repetitions. Resolving the discrepancies is necessary to secure the trial validity. There are inevitable discrepancies between the two systems. The safety or pharmacovigilance path involves using a distinct safety database, such as the Argus ® safety database, to record SAEs and to report Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) to Health Authorities. The clinical path involves using Electronic Data Capture (EDC) tools, for example Medidata electronic data capture (RAVE ®), to record any observed adverse event (AE) including serious adverse events (SAE) and adverse events of special interest (AESI). The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 17 of the world's top 25 global pharmaceutical companies, from study design and planning through execution, management and reporting.Safety data are collected via two different paths during clinical trials: the clinical and the safety paths. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including nearly 800 global pharmaceutical companies, innovative biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations. Medidata (link is external) is reinventing global drug development by creating the industry's leading cloud-based solutions for clinical research. For further information about Pharm-Olam, please visit About Medidata From Phase I to Phase IV, Pharm-Olam focuses on delivering the highest quality data, achieving targeted enrollment and meeting projected timelines, making clinical research as Easy As I, II, III, IV™. Pharm-Olam International is a multinational Contract Research Organization (CRO) offering comprehensive clinical research services to the pharmaceutical, biotechnology and medical device industries. More information about Pharm-Olam and its full-service capabilities and offerings are available at or you may contact us via email at (link sends e-mail). Pharm-Olam operates in more than 60 countries worldwide, offering end-to-end clinical trial support for Phase I-IV clinical trials. Suri added: “Rave provides our team with the capabilities to manage every aspect of a sponsor’s data requirements, and monitor a development program’s status across every time zone.” “We look forward to working with the Pharm-Olam team, providing them with the tools and resources needed to be successful on a global scale.” Renee Hart, Senior Vice President of Global Partners at Medidata, said: “Medidata is delighted to forge this new relationship with Pharm-Olam, a forward-thinking organization whose operational and therapeutic expertise is driving medical innovation and hope for patients,” said Hart. A sophisticated software platform is critical to our long-term success, and we need something proven, scalable and comprehensive.

“We’ve been hard at work, over the past 12 months especially, refining our Data Management offering. “As part of our ongoing efforts to implement a fully integrated data management method, Pharm-Olam is leveraging Medidata Rave to power our strategic data management initiatives,” said Sanjiv Suri, Pharm-Olam Chief Executive Officer. Part of the Medidata Clinical Cloud (link is external)® platform, Rave is a highly scalable, unified SaaS solution that enables users to manage clinical data from multiple sources, as well as quickly analyze and extract information for real-time decision-making throughout a clinical trial. Pharm-Olam International Ltd., a multinational, full-service clinical research organization (CRO) serving the biopharmaceutical and medical device industries, today announced that it has deployed Medidata Rave (link is external)®-the industry’s leading electronic data capture (EDC), management and reporting tool-to streamline its global Data Management and Reporting services.

DMPK and Translational Discovery and Development.

Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD).

Clinical Pharmacology Integrated Drug Development.

Clinical Pharmacology Modeling Simulation.

Biostatistics and Statistical Programming.

Chemistry, Manufacturing, and Controls (CMC).

Regulatory and Drug Development Consulting.

Inform edc medidata rave