The world is ever-so changing with our social, economic, and political differences these days, but one unwavering constant is that data must be standardized for the good of any industry. Our industry, Pharmaceuticals and Biotechnology, is dependent upon accurate and high-quality data that is collected properly, reported, and delivered to analysis groups for review in the clinical trial process. Below we will look at some of the latest Data Management tools and strategies to get molecule-to-market in the safest and time-efficient ways.
The new Data Management Landscape
- Quick Turnaround in Database Migrations
- Hiring highly skilled resources for EDC Database Builds on all the most current platforms (Medidata Rave and Veeva)
- Programmed Smart Listings for expedited and comprehensive data review
- Utilization of Data Visualization Tools and Artificial Intelligence
Breakthrough pharmaceutical compounds are meaningless without accurate, comprehensive clinical trial data and the right data management partner. Without reliable data, pharmaceutical companies are unable to provide the safety and efficacy validations needed to bring therapeutics to market, and to the patients who need them. With the right Data Management partner, sponsors can feel confident that their submissions have a high data integrity, and the best opportunity for drug approval.
Unfortunately, in today’s fast-paced, high-pressured clinical development environment, challenges exist with maintaining the cleanliness, completeness, and overall quality of clinical trial data. Clinical teams are spending valuable (and costly) time cleaning data rather than analyzing it. This time-wasted reconciliation is a major detriment and can result in small snags to severe setbacks that could potentially require a re-run of the trial. This challenge will only become more difficult to navigate as the volume and variety of EDC-driven data continues to increase throughout the trial. Experienced and highly skilled data managers are required to navigate around the unpredictable corners of clinical databases. To achieve both successful and compliant start-up through close-out data activities, a strong Data Management Team can confidently drive your data towards study lock.
Navitas Data Sciences’ answer to these challenges is to hire and retain the best Data Managers and Project Managers. We empower our Data Management Project Managers to ‘own’ their studies, and passionately conduct them from a Project Management standpoint. Our forward-thinking Senior Associates understand the ‘molecule to market’ process, and can build protocols into live databases, and can swiftly migrate databases when necessary (on average a database migration can take anywhere from 15-35 days depending upon the complexity).
The Navitas Data Sciences suite consists of Data Managers, SAS Programmers, EDC Programmers, and Biostatisticians who are embedded in any size client account. Smart data listings and decreased manual reviews allow us to improve efficiencies as data flow increases. Knowledgeable edit checks and well-programmed dynamics that enhance entry accuracy (at the Site level), greatly accelerate the back-end analysis and review processes. These tools (especially when coupled with Spotfire or Tableau business intelligence), can be used to optimize comprehensive data collection, data analytics, and data visualization as we move forward.
The end-to-end Data Management project ownership in Navitas Data Sciences’ data governance and meticulous understanding of the study (and clinical trial processes) are what allow our managers to confidently drive trials forward successfully. Our Data Management Teams can chair Data Review and Working Group Meetings, create study matrices and dynamics, write complex edit checks/UATs, perform reviews during study conduct (ensuring data entry completeness/cleanliness), and meet database lock timelines consistently. We see the remedy for the aforementioned ‘future Data Management issues’ in the distinct and high-caliber people we hire and retain. Their expertise and foresight enable them to swiftly navigate the unexpected variables that routinely occur in the new landscape of where new sources of data, Artificial Intelligence, and EDC Data Management systems come together to improve the efficiency of trials.
Protocol Amendments continue to be a necessary and frequent part of the clinical research process. It is important to test, validate, and transfer the updated data with confidence so that the process can be furthered along with programmer validation. This process is an intimate step between the functional service provider and its client clinical team. It is a crucial step in the relationship where confidence and reliance on the Functional Service Provider begin to cement itself for a long-term partnership, which is our goal at Navitas Data Sciences.
Navitas Data Sciences (NDS), is a specialty Clinical Data Functional Service Provider (FSP), delivering quality statistical programming, clinical reporting, and clinical data management services. Our capabilities include Clinical Data Management, Biostatistics and Statistical Programming, Data Standards, and Conversions.