Article Blog October 26, 2018

How Did Clinical Trial Project Management Get So Far Off Track—And How Can We Bring it Back?

In a recent webinar I hosted with Heather Davis  on the topic of clinical trial project management for clinical trials, two audience QuickPolls revealed the following:

  • The biggest challenge clinical trial project managers (PMs) face is the fact that current systems and processes don’t allow for a strategic approach; and
  • The most important investment area for enhancing project management in clinical trials is shared data among CROs and sponsors.

Our informal webinar polling dovetails with information from more scientific surveys. For example, the Veeva 2017 Unified Clinical Operations Survey reveals that the goal of unifying clinical applications — EDC, CTMS, and eTMF — is nearly universal.

Project Managers Aren’t Born to Be Taskmasters

While project management is one of the most important roles in conducting effective clinical trials, it’s also one of the most misunderstood. Sponsors don’t know why project management costs so much. CROs are frustrated by PM turnover. And PMs themselves are overwhelmed by job responsibilities they never expected to have.

Ideally, PMs should act as clinical trial navigators, providing the strategic vision required for successful trial completion, on time and on budget. PM’s should add value by helping to ensure patient safety, dealing with regulations and financial issues, and making decisions that determine whether to continue a drug’s development or terminate projects when necessary.

In practice, however, PMs are often distracted by inefficiencies caused by manual, error-prone workflows. Clinical trial quality suffers and PMs are seen as expensive taskmasters who spend too much time updating trackers, sending emails requesting information, and reminding team members about upcoming deadlines. The best PMs often quit out of frustration, which puts precarious trials at even greater risk.

Technology Can Elevate Project Management and Energize PMs

To optimize project management and overall clinical trial performance, sponsors and CROs must embrace data-based technology solutions that provide:

  • Automated data unification from different sources
  • Data visibility in visual, role-based dashboards
  • Real-time analytics and reporting

When relevant data is centralized and accessible, every stakeholder can align on what makes a trial successful and the roles and responsibilities of each team member. This sets up a business process that allows sponsors and CROs to work from the same data and quickly resolve any issues that might arise.

In Practice: Technology

Best practices around data collection and visibility lead to collaborative, proactive issue resolution.

To facilitate this type of collaboration, CROs and sponsors must establish data transfer agreements that outline each data source, the data points captured from each system, and the timing and method of each transfer. Data standardization rules are also important, especially if you are comparing sites and studies over a larger clinical trial portfolio.

The next step is to automate your quality agreements and oversight plans. This is how it works:

  1. First, the sponsor and CRO identify the key performance indicators (KPIs) needed to ensure that plans are met.
  2. Next, the sponsor and CRO review the KPIs periodically and make any necessary changes.
  3. Third, the sponsor and CRO put systems and processes in place to proactively monitor data and alert appropriate team members when thresholds are breached.

With these technological building blocks, sponsors and CROs can collaborate in a fully transparent environment. Because key risk areas can be monitored in real time, questions about study delays, enrollment leakage, protocol deviations, adverse events, and queries can be answered and acted upon immediately by the right people.

Knowing that administrative tasks are automated and that the data being used is complete and consistent, PMs can breathe a little easier. Instead of chasing down information, they can deliver excellent service as the trusted, strategic partners sponsors and CROs expect and deserve.

To learn more about best practices for strategic project management — from both CRO delivery and sponsor expectation perspectives — watch our 30-minute webinar on demand now. You — and the PMs you work with — will be glad you did.

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