The second part in this series discussed the entire RFP workflow from planning though selection of the best-fit CRO and included a documentation checklist and scorecard to lend practical support to sponsors. But now that you have selected a CRO and execution challenges are bubbling up, what can you do?

Despite judicious planning, clinical trial execution is fraught with complications and expected challenges, as well as unforeseen risks. For this reason, we don’t see articles on CROs exceeding expectations other than a rare white paper or case study. Even then, the details may be so specific that teams cannot extrapolate these pearls of execution wisdom to their own trials. Add to that sponsor teams under pressure to deliver results in a fast-paced research environment with resource constraints and operational risks, and the resulting situation can present several operational challenges related to CRO outsourcing:

1. Lack of Specificity

A common pain point is that CROs often only provide the basic information to meet the statement of work or deliverable. Sponsors often look for details to help manage risk, but the CRO doesn’t show the sponsor they have done their homework by providing critical analysis. An example would be recruitment metrics that don’t explain site underperformance. Sponsors are looking for CROs to be able to explain and pivot on feasibility projections that turn out to be unrealistic.

Best Practices:

To combat lack of specificity, establish deliverable acceptance criteria for all key program documents at the onset of the CRO relationship. Whether it is an outline to follow for meeting minutes or a table of contents for a report, managing expectations from all sides is key. One way to ensure positive enrollment is to utilize predictable sites and site networks. Another best practice is to use key performance indicators (KPIs) (e.g., cycle times, error rates, deviations, and change orders) as standardized metrics to ensure quality and performance. This also allows sponsors to identify and apply lessons learned throughout the project.

2. Lack of Transparency

When CRO teams don’t meet expectations with communication, sponsor teams get concerned. CROs that also use various systems and don’t provide access to the sponsor create trust issues. Additionally, when a document sharing system is used but not regularly updated in a timely manner, transparency and confidence declines.

Best Practices:

A good strategy is to have a communication plan that incorporates roles, responsibilities, governance, escalation, and frequency and types of communication methodology/tools. Sponsors that manage according to a solid plan with the CRO ensure the project operations are clear to all stakeholders. Sponsors that share new product development plans or changes to R&D timelines will often foster better collaboration and agreement on revised operational plans.

3. Long timelines

Nothing is worse for a project manager (PM) than when timelines slip. When timelines slip, costs often increase. When this happens, sponsors often share they don’t feel the CRO took all tasks or risks into consideration or that the duration of the task is too aggressive. When a PM realizes several tasks on the critical path are unrealistic, the expectation is for the CRO to make it up elsewhere.

Best Practices:

To critically analyze project tasks, pare down each task into subtasks and incorporate risk time if the task has a probability of a delay. Also, share the R&D timeline that affects the CRO to proactively assess the resources assigned to tasks at both organizations and if the critical path is realistic.

CRO Oversight Post ICH GCP E6 (R2) Addendum

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Find out more in SAM Sather’s webinar.

4. Generalists vs. Specialists

Inappropriate CRO resources that lack therapeutic area depth can result in poor-quality operations and deliverables. This can be avoided with project resource planning and skill gap analysis.

Best Practices:

To ensure the CRO has put forth its A team, sponsors should identify the minimum qualifications for each functional area of the project and a training plan. Additionally, performing an assessment of SOPs and a skill gap analysis for CRO organizations will help identify risks and optimize operations.

5. Dedicated Resources

A common complaint from sponsor companies is that CROs do not give the time commitment they were expecting. This can lead to delays and the perception that things are not getting done. CRO staff members are often on several sponsor projects, but understanding the percentage of their work week allocated for your project may manage expectations and reduce poor perceptions. Turnover, lack of CRO resources, or a disconnect between bid and execution of team members (yes, this is still happening) can be thwarted with a staffing management plan.

Best Practices:

Staffing/resource management plans should include methods/tools, key/lead staff requirements, staff acquisition, roles and responsibilities, training requirements, and transition planning. This type of documentation also eliminates unnecessary overlap in responsibilities.

Transforming Clinical Research Practices

With CRO challenges, organizations look for ways to better manage the CRO relationship, build on standards, and improve and measure performance. For example, in 2016, the Metrics Champion Consortium (MCC) surveyed large and midsize sponsor companies and found nearly two-thirds were using a standard set of KPIs.1 They looked at corporate- and functional-level KPI metrics. These KPIs are primarily driven by clinical operations, data management, quality management, and finance. Most would agree this stands true in today’s market. At the functional level, the most common included investigational sites being activated on time, enrollment completing on time, case report forms finalized (i.e., clean data) on time, and the trial database being locked on time. KPIs are best utilized to measure performance against the contracted tasks. Meaning, it is more effective to measure the time it takes for a CRO to initiate a site after institutional review board (IRB) approval than to measure how long it takes for a site IRB to approve a protocol. It comes down to the CRO’s direct tasks on contract, not a third party’s performance.

In addition to KPIs for better management, both sponsor organizations and CROs have an opportunity to change the relational ecosystem with the use of novel approaches and innovative technology. Whether it’s automated data collection or technology that aggregates data from various sources, the burden of data collection is minimized, more transparent, and standardized2 across organizations.

We are on the edge of exciting, transformational clinical research practices. Once the best practices become the standard operational framework within life sciences companies, robust performance and optimized trial execution will benefit all.

References:

About the Author:

Joelle Herman is the president of NeoTrials, LLC and brings over 20 years of experience in clinical research. Her expertise is in clinical operations program management, focused on outsourcing management. She created NeoTrials after years of consulting to small biopharma and other firms. Prior to consulting, she served as director of clinical operations at DynPort Vaccine Company LLC. Earlier in her career, Herman led global clinical programs for organizations such as Oxxon Therapeutics/Oxford BioMedica, AAI Pharma, Antigenics Inc., and Apheresis Technologies, Inc. She has conducted and managed over 30 global trials in drugs, devices, and vaccines, including well-known products. Herman has a Master of Public Health in epidemiology and a Bachelor of Science in microbiology, both from the University of South Florida, and is a Certified PMI Project Management Professional. Connect with her on LinkedIn.

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