Project Management in CROs

The ever changing and challenging field of generic drug development combined with greater regulatory and competitive landscape led to increasing pressure to be innovative, cut costs and run lean. In this context, CROs have become an integral part of the generic company’s strategy that allows them for optimum allocation of human and capital resources. Driven by mounting market pressures, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development by decreasing their in-house facilities and staff, and outsourcing more of their R&D functions.

There are specific CRO’s for every aspect of generic drug development. It goes without saying that in choosing a CRO, the primary focus should on the quality of the work and deliverables. It will be a huge burden on the time, capital and human resources if the study has to be repeated.

As with any project, communication is key and there should be a single point of contact for sponsor and CRO. Usually the representative at the CRO is a study director or project manager depending on the scope of the study. From the outset, the project manager is responsible for prompt and open communication with the sponsor to ensure progress is transparent and that any major issues are discussed and managed in a consorted effort.

A project at a CRO takes a multidisciplinary effort for the success. For example, sponsored development programs involve the expertise of several individuals and disciplines with distinct expertise in regulatory, formulation, analytical, clinical monitoring, quality, supply chain management, finance, data management, etc. and these should work closely and seamlessly for a project success.

Planning and Set-up Phase

Project Plan:

Proper planning is key for the success of the project, the better the planning up front; the smoother the progress of the project. Develop a project plan with clearly stated timelines and milestones that are realistic, achievable and accountable. The plan should be in a clear and understandable fashion, ensuring that assumptions and justifications are clearly documented. The CRO and the sponsor should be in constant communication to understand the scope of the project in great detail so that expectations for both sponsor and CRO are aligned. For instance, if the sponsor wants to expand the scope of the study before the start, then the timelines should be revisited to see if they will impact the time required to complete the project. All deliverables and assumptions must be clearly documented along with the risks and their corresponding contingency/mitigation plans. A time and resource plan must be agreed and the contingent clauses that might affect the deliverables must be understood by both parties. All the expectations along with sample shipping, handing, experimental design, analysis, data generation, maintenance of data and records should be documented in a protocol, which should be signed by both the parties.

Regulatory Compliance:

The sponsor and the CRO should have agreement on what kind of regulatory guidelines in the study needs to be followed. They should also state all the pertinent regulatory compliances according to the scope of the study (e.g. FDA/EMA, state and country regulations). The sponsor and CRO should agree on standards and SOP’s to be followed along with electronic data capturing devices that will be used (software applications).

Budget and Resource Allocation:

Negotiate the scope of work, timelines and the proposed budget. Ensure that sufficient resources and budget are available and allocated to allow a satisfactory outcome. Ensure a process is in place to allow regular review of the budget against tasks and assumptions.

Risk Assessment:

Identify potential areas of risk based on the project plan and assumptions. Establish a process to review the risk on an ongoing basis ensuring sufficient contingencies are built into the plan based on risk analysis. Create a tracking system to document and manage the risk for the project.

Start-up Phase

Communicate the project plan to the team and obtain agreement from the project team for all assigned roles and responsibilities, key milestones, timelines and budget. Have a pre-initiation meeting with the team to go over the protocol and talk to the team for any questions or concerns.

Study Phase

Proactively assess project progress against the project plan and implement the project contingency plan when the project is out of scope. Have an open dialogue and obtain agreement from key stakeholders for any changes in the project plan that may affect the project’s critical path. Communicate to obtain accurate and timely status updates.

Team management:

Ensure that the team has all the resources for a successful project completion. Ensure that all team members have the right training to perform the project tasks.

Completion

Ensure that the CRO sends all deliverables as agreed in the project plan. Evaluate the performance of the project team against the project plan.