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MakroCare’s Drug Development Informatics- Products And Solutions

24th August 2010
MakroCare With a unique blend of functional team (consisting of Physicians and PhDs) and technology team, DDI is strongly positioned to provide products, solutions and services to meet the Clinical IT infrastructure challenges of client. MakroCare development lifecycle depth combined with business process breadth helps to provide strategic technology services & solutions to specifically address areas that are most important and relevant to the clients’ ever changing and highly regulated professional environments. DDI’s core offerings are divided between products and solutions. Drug Development Informatics(DDI )Products: mEDC:(Electronic Data Capture System): a web-based technology for managing single or multi-site clinical research studies with complete audit trail. The architecture provides a secure, robust and extensible system for managing multiple clinical research studies within a centralized repository mIVRS:(Interactive Voice Response System): uses telephone technology. It provides logistical support that is in an important component of a clinical development program. It is used for patient randomization and enrollment services. JarTree:(Document Management System): a web based document management system mainly developed for storage and retrieval of documents. Framework involves document repository where documents are stored in a hierarchy structure, version control that includes check-in and check-out. mCTMS:(Clinical Trial Management System): is a powerful tool that MakoCare utilizes for managing clinical trials in multiple countries. mCTMS is a thin-client web based technology taking the most advanced features of the Internet including XML support, facilitate the sharing. mSignal:(Advers Event Signal Detection System): Pharmaceutical companies have a requirement to conduct continual signal analysis as part of a Risk Management Plan to: Protect patient safety, Meet regulatory requirements, Understand risk-benefit ratio of a product, Discover Product-AE relationship, To gain competitive advantage. Makro Signal detection tool meet all above-mentioned requirements. And it include all relevant data sources (Clinical Trails, Individual Case Safety Reports, periodic safety update reports, registries and External data bases -FDA, WHO etc.) Benefits of Using DDI Products: • Best ROI • Faster Deployment • Open Standards • 21 CFR part 11 • Hosted • Multilingual • 24x7 Support are the common benefits for all DDI products DDI Solutions: Oracle Life Sciences: DDI being a partner of Oracle has in-depth implementation expertise of Oracle Applications Suite for life science industry. Some of the products include: OC - Clinical Data Management System, Oracle Thesaurus Management System (TMS): Medical Dictionary like: WHOdrug, Meddra, Management framework, Oracle AERS- Drug safety data capturing, assessing or analyzing and regulatory reporting system. Microsoft Solutions: DDI is a leading provider of services and software for Microsoft products: Microsoft Business Solutions CRM or Microsoft SharePoint, to provide service with professionalism and years of experience. Regulatory Compliance: Life Sciences companies operate in a highly regulated environment that is continually growing and evolving as regulations and guidance criteria change. MakroCare developed an innovative program called PPR (Planning/Perform/Results) to help the clients maneuver through " and meet " regulatory requirements. Using a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis, MakroCare will develop a customized plan for your business to determine accurate, actionable, and achievable steps that yield results Systems Integration DDI has deep expertise in consulting services that are critical to the various functions and practice areas covering pre-clinical, clinical to marketing. The professional consultants who concentrate solely on this industry have helped clients all over the world implement strategies and solutions grounded in solid business principles, aligned to each company’s business goals and objectives. Content Management and Portals: Intranet, extranet and portal solutions can help you meet your business needs for information sharing and collaboration, both within your company and with the outside world, The company has been developing these solutions since the advent of the commercial web. Click Here For More Info:
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