The most fundamental requirement of clinical research and the ability to gain approval for new drugs and devices is the generation of high-quality data. The advent of Big Data and precision medicine and the focus on reproducibility in research places a bigger burden on scientists to ensure the data they produce is reliable and accessible. Combining large amounts of genomic data with clinical information presents major challenges in both data management and integration activities. Many journals and grant providers now require electronic data submission, and FDA is moving towards even greater standardization in electronic submissions. This environment presents several challenges, including technical choices, but focusing solely on technology will not address the larger issues nor ensure effective planning for the future.
Essex has many years of experience working in the CDMS space, and understands the core needs as well as what has emerged as the space has evolved. Creating solid workflows and efficient processes around data management and the CDMS application are critical to success. Integration with other systems in the clinical and research space are also crucial. This must be combined with an understanding of the regulatory environment, and the impact of technology on the patient. Essex brings a broad and strategic perspective to our clients’ CDMS needs to ensure the most efficient and cost-effective approach, but one that will also provide for future needs.
Meet Frank Spina
Sr. Associate and
CDMS Domain Lead
Frank has over 30 years of experience working in clinical data management systems, including as a Senior Principal Consultant for Oracle and managing the CDMS Practice for a NY-based consulting firm specializing in Health Care and Clinical Research. He has worked at one of the largest pharmaceutical firms in the world as an Associate Director, representing both IT and Regulatory Affairs, and has expertise in all the leading, current CDMS systems. Frank holds a Bachelors in Biology from the University of Pennsylvania.