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San Diego at sunrise

The biopharma industry is under constant pressure to speed deliverables and reduce expenditures, but we cannot lose focus on patient safety. To achieve this balance, companies may want to consider utilizing tools such as visualizations as part of a centralized Risk-Based Monitoring (RBM) and adaptive trial design strategies, to gain a more holistic view of data so they can identify trends faster, improve cycle times and eliminate white space in the process.

The Society for Clinical Data Management (SCDM) annual event to be held from September 11-14 in San Diego, is an opportunity for fellow professionals to further consider their role in getting better treatments to patients faster. As a clinical data management professional, I look forward to this event every year. SCDM is the only global association for CDM experts, and this is a unique opportunity for professionals to come together and discuss the latest data management trends in the research environment, talk about new, innovative data solutions, and share ideas and best practices for our future endeavors.

Given my belief that we are pivotal to driving change in the drug development process, I’m particularly interested in connecting with my peers and exploring the potential integration of data management, biostatistics and medical writing services. Although each of these functions works well on their own, there is a growing conversation about the value of integrating these workflows under a single leadership team or vendor to create synergies between the functions that can drive efficiencies, reduce costs and improve quality in data management processes. The technology exists today to bring these functions together, and I’m eager to see how this approach can positively impact clinical research.

There are a number of valuable sessions on important industry topics worth checking out at SCDM this year. Here are some that I’m most excited to attend:  

  • On Monday, Jessie Chen from Pfizer will lead an interesting session on Quality Oriented Data Management Evolution in China. The current world population has reached approximately 6.7 billion and China represents 20 percent of that population, or one in every five people on the planet. It’s not surprising therefore that the biopharma industry needs to conduct studies in this population and thus China has become an increasingly important destination for clinical research in recent years. However, navigating the shifting regulatory environment can be challenging. This session is offering an overview of the regulation changes that have occurred in the past year to improve clinical trial data quality in China, and an opportunity to discuss how data management professional capacity in China could expand. 

  • On Tuesday, Quintiles’ own Arshad Mohammed will lead a session on Data Management Considerations in Observation Studies. This topic plays to another key industry trend, which is the need to provide real-world evidence of value to regulators and payers alike. These research initiatives demand a unique data management approach that isn’t always well understood. A lot of investigators try to force fit early phase data management practices into observational research, but that can result in data issues during study conduct or close-out. Arshad will explore how to create an appropriate data collection system and process for these studies, how to plan for missing data and how to work with epidemiology and biostatistics teams to deliver the right data management solutions and services for such studies. 

  • On Wednesday, a session on eSource, which will be led by Ed Sequine, CEO of Clinical Ink, will explore the use of electronic sources for data capture, data review, data access and the use of computerized systems in clinical investigations. The session will also cover the impact eSource can have on data management processes, address issues such as how to deal with eSource data that cannot be independently verified and include several case studies and best practices. These are timely topics, as eSource tools can greatly reduce the need to track down source data and enhance information gathering when implemented effectively. Learning more about how other industry experts are incorporating these tools into their data management flow should also be enlightening.

Regardless of which session you attend, hopefully all participants will come to this conference eager and passionate to learn and work together so that we can continue optimizing data management processes for clinical research with the ultimate goal of contributing to a healthier world. Also, I’m personally excited to reconnect with colleagues and peers in breakout sessions and informal meetings to talk about the accomplishments we’ve achieved and what the future holds. It should be an informative and educational event, and I look forward to seeing you there.