In clinical operations, studies are complex and time intensive. In fact, every clinical trial is a single project that requires investment in proper planning and leadership to be successful. Managing central labs, IRT/IxRS, eCOA and patient recruiting vendors, reviewing the Investigator Site File, remaining compliant with all industry standards while keeping a close eye on enrollment, only represent a few of the responsibilities of a clinical project manager (CPM). Several technologies can streamline and automate specific workflows and provide CPMs with greater visibility and insight in the trial data. Hence, it emphasizes the importance and benefits of a purpose-built Project and Portfolio Management (PPM) tool within the clinical trial landscape:
- Quick and easy capturing of milestone trial activities: Time is invested in collecting the standard operating procedures from vendors and stakeholders, outlining country vs. site activities and putting them in an organized hierarchy of various tasks. Mapping and linking these multi-disciplinary deliverables in a well-designed PPM tool could avoid significant delay in trial start-up and highlight any rate-limiting factors (e.g. prolonged contract negotiations or mandatory drug import license) that might endanger your site enrollment.
- Keep your budget and resources in control: Keeping sites open that are not meeting their enrollment goals only take up resources that can be better re-assigned to other demanding projects. Tools supporting time reporting, progress tracking and frequent budget reviews can assist with detecting a potential overspend or misalignment in resource allocation.
- Smooth collaboration within your cross-departmental teams. For regulatory teams working in the versatile field of protocol amendments, it is valuable to spot the status of a country-specific document in an eyesight or person that is revising the informed Consent Form. Where a simple Kanban board might work for single-country studies to ensure a timely submission, extra layers of approvals are required for complex, international trials, which in turn call for more advanced tools.
- Engaging external business partners via transparent data sharing. Making the investigators part of risk mitigation and enrollment strategy discussions can speed up the identification of potential roadblocks. Engaging stakeholders via role-specific access settings to your PPM tool can simplify stakeholder communication and ease requests for changes.
- Easy-to-read and predictive visualization tools. Combined with data-driven intelligence applications, customizable reports can add value throughout your trial life cycle, ranging from supportive graphics for funding applications, facilitating budget forecasting exercises to pinpointing potential risks.