DDi: Strengthening Clinical Data Management
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DDi: Strengthening Clinical Data Management

With the gradual evolution of technologies and tools for data management in clinical research, companies have been developing tools in silos with specific capabilities, serving multiple purposes. However, most of these tools are found to have less or no integration between them. Currently, most of the data preparation and analysis is a manual process when it comes to cross-functional teams. To add to the complexity of the process, this data may be coming in from different technical vendors who are not integrated with any data standards. Nullifying these challenges is Drug Development informatics (DDi). Headquartered in Princeton (NJ), DDi assists its clients with an exclusive mix of functional and domain expertise to meet the data management & integration requirements. “DDi products and solutions are built from ground up with ‘integration’ as the foundation—both within DDi products and with other 3rd party vendor products,” says Mahesh Malneedi, President of DDi.

With advancement in the digital space, all its clients can now access data available through new interactive technologies—DDi having adapted to most of the latest technology developments for clinical operations, whether it’s a multi-device application availability or Non SQL databases (NoSQL) or Analytics. “Clinical operation is a highly cross-functional process where data moves across different functions leading to more informed and quicker decisions,” says Malneedi. Leveraging DDi’s proprietary BIG Analytics solution for better central statistical monitoring methods, DDi’s integrated analytics solution, ClinMetanoia facilitates data capture in real-time with advanced analytics thus driving down implementation time. In addition, DDi provides a single sign through portal in an organizational framework called mPortal, which is important in terms of security and ease of accessibility.

Breaking away from conventional thinking process, DDi developed innovative solutions which facilitate Real-time decision-making, Risk Based monitoring, Oversight/Governance, Central Statistical Monitoring, and key analytics all accomplished with a single integrated platform.
Leveraging clients’ assets instead of starting solutions from scratch—DDi’s solutions ensure faster implementation of RBM and Oversight projects as most of the pieces are pre-built. This enables functional teams to show the results faster in their projects and programs as opposed to in most IT projects, where quantifying ROI takes very long time.

DDi products and solutions are built from ground up with ‘integration’ as the foundation


DDi’s customer base includes organizations present at the pinnacle of global R&D, which includes big pharma, mid-size biotechnology, and medical device companies. DDi’s solutions, for their clients, collect data from multiple systems, which often pose a question of data integrity maintenance. Maintaining a single version of truth, Master Data Management (MDM) helps DDi to overcome that challenge. “We put in place policies, processes, standards, and tools that help us man¬age the critical data. With MDM, we remove duplications in data and give a single point of reference, even though data is coming from different sources,” explains Malneedi. DDi also works towards standardizing the data and incorporates checks and balances to see that incorrect data is prevented from entering their system.

So what’s next for DDi? The next step in the Pharma industry is Clinical Research risk management. As drug development costs have crossed $1 billon per drug, DDi developed a risk management solution, “TULA” to alleviate the risks in the market. Moving ahead, DDi aims to be innovative by utilizing functional domain well and bringing “data costs per patient” significantly down. “Staying relevant is the key for continued success. In this industry, it is comparatively easier as the end benefactor is patient and people get passionate about taking part in this cause alongside constant solution exquisiteness,” summarizes Malneedi on an ending note.