MakroCare: Weaving Smart & 'fitfor-purpose' Solutions to Accelerate Clinical Development& Regulatory Science
Date: Monday , April 11, 2016
Decoding of human genome has opened up a completely new segment and perspective of curing diseases from patient standpoint, as some therapies respond to few patients and not others. Data gathered from various resources being the foundation for determining safety and efficacy of these new therapies, it should be integrated to obtain a holistic view. Moreover, this massive genomic data needs high computing power for proper and faster analysis.Providing data analysis with its customized algorithms and models,DDi(Drug Development informatics)has been successfully accomplishing this since 2009. Sprouted its root under Makro Group(a celebrated organization enriched with two decades of experience in running the solutions and services for Pharma industry)as its technology subsidiary, DDi carries the legacy and maturity of such vast experience.
Breaking away from conventional thinking process, this Hyderabad-based teamhas developed innovative solutions that facilitate real-time decision making, risk based monitoring, oversight/governance, central statistical monitoring and key analytics all accomplished with a single integrated platform. Better yet, during this process, DDi leverages client\'s already existing assets, instead of starting solutions from scratch. Hence, sponsors can achieve high quality clinical informatics and intelligence pertaining to clinical operations, safety, data quality and regulatory compliance.
Furthermore, focusing on \'smart\' features has enabled the company to offer cost-effective and robust IT products namely mEDC, mIRT & mPORTAL in clinical development area and smart solutions akin to ClinMetanoia to global companies. For instance, mEDC\'s simplicity, feature richness, faster study setup and capability to provide best ROI has recently magnetized a global top Pharma major to sign up for a major study with 17,500 patients. These products are fully validated following 21 CFR Part 11 guidelines and support regulatory guidelines standards like ICH-GxP, CDISC, HIPAA, and HL7.
\"We are operating in an industry that deals with the most fragile Human - patient. So we strive to endow clients with a safe, timely and quality services & products without any excuses & compromise. We have weaved our work around the services and technologies for pharma & biotech industry, where the patient is kept at the center of our work,\" says Mahesh Malneedi, President & Co-Founder, MakroCare.Amidst the constant rise of costs that require bringing new therapies to the market, clinical development consumes major pie. However, constantly on the run to upgrade itself has kept MakroCare ahead in any kind of challenge.
Grow & Let Grow
Unless and until the deserved scope is given to the people who are the heart of any organization to accelerate in learning and implementation, the organization can\'t proceed. Firmly believing this philosophy, MakroCare inculcates this in its people\'s minds as well.Growing in an industry that demands constant upgradation, insight and R&D, the company keeps its people updated on the latest technology trends via training and participation in various knowledge platforms, webinars and conferences.Focused in development area currently, DDi aims to expand its current products into other territories and it\'s keen on chiseling its analytical solutions, so it can be applied very effectively on the commercial side as well.