The pharmaceutical industry has steadily transitioned away from paper-based clinical projects and embraced the use of electronic data capture (EDC) systems and tools to run Phase I, II, III and IV studies. The options available to the various industry groups (biotech startups, contract research organizations, small, medium and large pharmaceutical firms) have changed over the past several years, as have the companies involved in delivering EDC applications and services.
In general, industry can choose from the following core options:
- On-site or on-premise EDC solutions
- On-demand EDC solutions utilized on a per-study (or multiple study) basis
On-site or on-demand solutions: Making decisions
The decision to choose an on-premise EDC system is far more complex than solely working with an EDC vendor. Elements such as how the system will impact internal resources and processes, staff requirements, technology responsibilities, and the financial calculations to determine the impact of the capital investment on overall profitability must be approached before finalizing such a key structural/service implementation. Emerging companies, such as start-up biotechs, small to medium CROs and pharma companies will generally view on-demand EDC as the logical step in the transition towards using EDC clinical research tools.
Core Tasks: On-premise vs. on-demand solutions
When choosing between on-premise solutions, or working with an on-demand EDC vendor, there are various tasks that must be approached. These represent a high-level view:
The economics of on-premise EDC in today’s business environment
On-premise EDC systems bring control, process and overall management within the organization that acquires and integrates the solution. One of the major considerations is financial viability – whether the investment in an on-premise solution is the right approach in today’s business climate. The major capital investment, ramp up process, additional staff costs, system validation and operational requirements all contribute to the significant commitment that must be made by an organization when installing an in-house EDC solution. If a company can adequately map out the next 2-3 years of clinical studies and associated business activities, and is willing to assume the management of software/ hardware systems and personnel, it can be a very reasonable approach to managing costs and project deliverables.
For most companies, on-demand solutions reduce the risk to EDC adoption and, in the long run, prove more cost effective. This path allows for greater flexibility in determining the right solutions, provides for multiple EDC partnerships to accommodate various client requirements, leaves responsibility for technology management to the vendor, and significantly lowers the financial commitment by avoiding a major capital expenditure.
Choosing the right vendor: Key considerations
Regardless of the approach, it’s important to evaluate vendors from various perspectives before making a decision:
- Do they deliver results-oriented EDC solutions?
- Do they regularly succeed in delivering effective project implementation and management?
- Do their existing clients confirm their product quality and overall level of service?
- Are their EDC tools friendly, usable and effective for the key stakeholders (coordinators, monitors, investigators and data management)?
Regardless of your choice of vendor make sure that you build a strong relationship as your mutual success is directly linked. Strong communication, detailed project management practices, a cohesive team structure and intuitive, end-user EDC tools and services should ultimately enhance the delivery of high quality, credible clinical research data.
JAN