DDi: Creating a Culture of Compliance

Mahesh Malneedi, CEO

“In drug development and clinical research area, taking appropriate action on a project or a program or a vendor on time is very important as each day lost constitutes to millions according to several industry studies done,” asserts Mahesh Malneedi, CEO, DDi. As the Life Sciences industry is highly regulated and several compliance areas are to be followed at each stage, DDi provides solutions with an amalgamation of functional and domain expertise to cater to their global clients’ needs. The firm brings in a single centralized system that enables organizations to develop a single source of truth to employ systematic enforcement of risk and compliance across enterprises. DDi provides a portfolio of products that enforces regulatory policies and minimizes the risk within the organizations.

DDi caters to Clinical, Regulatory, Safety, and Enterprise domains with its innovative technology products and solutions for the Life Science organizations of various sizes. The company provides its customers the ability to identify and minimize the risk through its GRC tool, TULA. The firm developed TULA for drug development and clinical programs to anticipate the compliance related issues. “General GRC solutions will not be a fit for this industry and in particular to this area of clinical research as performance and risk linking is to be handled differently than other industries,” mentions Malneedi. TULA provides centralized vendor performance information to organizations and helps them meet regulatory compliance. DDi has helped several global clients with its flagship product, TULA.

One such global client initiated multi-vendor outsourcing of their projects to track programs and performance of their projects using a real-time system.

DDi simplified the complete risk management process right from identification to mitigation thereby providing high-quality clinical data and reducing clinical operational costs

The client approached DDi for real-time data gathering and to ensure that the multi-vendor programs operate efficiently. DDi, a technology partner to Life Sciences companies, streamlined the client’s project performance, vendor oversight, risk management, and compliance with the help of TULA. The client needed the same system to support Risk-Based Monitoring (RBM) of their clinical projects as well. DDi simplified the complete risk management process right from identification to mitigation thereby providing high-quality clinical data and reducing clinical operational costs. TULA saved a huge amount of time for performance and status reports generation by reducing manual efforts of project or program or CRO performance reporting.

In addition to TULA, the company also extends products such as mEDC, mIRT, mPORTAL, mCODER, and smart solutions like ClinMetanoia. The pre-built components in ClinMetanoia make it a smart solution thereby providing real-time access to data and analytics from various sources. Focused on ‘smart’ features, DDi delivers cost-effective and flexible products to pharmaceutical companies, small & mid-size biotechnology and medical device companies as well as academic/ research institutes. Their portfolio also encompasses products focused on regulatory and compliance like ViSU, safeXchange, and REGai. These products are validated as per 21 CFR Part 11 guidelines and support regulatory standards like FDA and ICH.

In an attempt to further build on TULA, DDi provides proprietary Artificial Intelligence and Automation platform— YANA. The platform amalgamates robotic process automation, AI, machine learning, and digitization to identify risk and deliver flexible business operations. Malneedi believes that automation and AI will substitute the legacy systems to mitigate risk. He claims that industry moving towards automation and artificial intelligence will challenge some of the legacy systems, and all industries need to look for efficiencies on how to incarnate these in their existing products and systems to stay relevant with customers.