Project Management

Transforming CRO Project Management

As a digital clinical research organization (CRO), Clinipace Worldwide is transforming the way project teams have traditionally functioned. In the digital CRO model, a common technology platform integrates the full spectrum of clinical trial functions, including project management. By applying proven clinical project management principles, our PMs effectively achieve milestones, meet project timelines, and optimize resources and communication pathways. We appoint an experienced project manager whose background and skills best match your project requirements. Our PMs, along with an executive sponsor, serve as a liaison to all project stakeholders.

With every project, Clinipace Worldwide appoints an experienced project manager whose background and skills best match the project requirements, and along with an executive sponsor, serves as a liaison to all project stakeholders. With a commitment to open and transparent communication our project managers provide:

  • GCP adherence
  • Project visibility and lifecycle management
  • Comprehensive project and communication plans
  • Collaboration with sponsor(s) to create data management, monitoring, and site management plans
  • Service & software coordination
  • EDC best practices
  • Training for investigators, site staff, and monitors on the protocol, eCRFs, data monitoring plans, SOPs, GCP

Commitment to Real-Time Visibility

What distinguishes our project management approach from traditional CROs is that we go beyond looking for top-notch clinical research professionals to manage programs. We provide our project managers with superior tools and technology by running all aspects of the study entirely within the web-based TEMPO™ platform. This provides our project managers and clients with real-time access to all trial data and metadata.

An unparalleled level of visibility into the activities of all project stakeholders, from sites to CRAs to lab vendors, allows for proactive and informed decision-making. By combining this increased level of information and analysis with the leadership of an experienced project manager we deliver superior performance and quality in our clinical trials. For our clients, total visibility promotes accountability and open, honest communication.

We leverage a team approach, with a dedicated Project Manager overseeing project plans, technology implementations, staff deployment and client interface. Our commitment to your project includes:

  • Project plan to ensure complete visibility
  • Executive sponsor to ensure accountability
  • Collaboration to ensure quality
  • Training to ensure adoption
  • Project team to ensure lifetime support
  • Account Management to ensure access

Managing Risk, Studies Managed

One essential aspect of project management is risk management. Briefly, we work during study planning with the project sponsor to agree on potential study risks along with the means to measure them. Central to this process is the creation of forecasts and timelines for key study activities, which can then be programmed into TEMPO™.

This enables our project managers to use their dashboard to track variance of key study performance metrics against plan, in real time. During this process, we work to identify risk mitigation strategies. That is the process of determining, in advance, what actions can be taken to avoid or reduce the probability or risks becoming issues. Finally, we work to agree upon pre-specified risk management actions that will be triggered when risks manifest as issues during the study.

This approach enables quick implementation of corrective actions to keep the study moving forward on time, on budget, and with the high level of quality required.

Breaking Down Walls, Facilitating Information Flow

The integration that characterizes digital CRO contrasts with the compartmentalization of the traditional CRO, where clinical trial functions are separated into silos. Walls that separate functions in the traditional CRO are broken down in the digital CRO, where information flows quickly and freely among project stakeholders. Technology-enabled processes obviate the need for hours-long meetings devoted solely to ensuring that all project stakeholders are abreast of the most current study status and issues.

We have a flexible model for working with Sponsors and have accommodated a single point-of-contact (the clinical PM) when requested or followed a model where functional leads are responsible for interacting with the Sponsor counterpart. In either model, the key is to clearly define the expected communication pathways, roles, and responsibilities in a Communication Plan.