Guest Column | March 14, 2024

A Better Recipe For Sourcing Your Clinical Trial

By Larry Blankstein, Blankstein Consulting Group, and Sophie Gorengaut, SuperNOVA Clinical Research, Inc.


As experienced clinical research professionals, we've seen significant changes in managing clinical study activities over the past three decades. Initially, most activities were handled by in-house staff, with only a few services outsourced. However, in the 21st century, companies faced challenges when clinical studies failed, choosing to respond to the financial implications by cutting what they considered excess staff. Outsourcing then became more prevalent to address the ensuing resourcing challenge, offering cost-effectiveness, scalability, flexibility, access to expertise, and risk mitigation. As a result, many clinical trial activities were outsourced to CROs, with some companies even transferring entire clinical departments to CROs instead of laying off staff.

Yet, do we still consider outsourcing the optimal pathway for conducting clinical trials in the 21st century? We would like to propose a better recipe for success with ingredients of insourcing and functional service providers (FSP), sprinkled with a handful of outsourced tasks, for a more stress-free and agile clinical trial experience, especially in clinical operations.

The Upsides Of Insourcing

Insourcing, also known as in-house or internal sourcing, refers to performing business functions or activities using internal resources and personnel within an organization rather than outsourcing them to external parties. In other words, insourcing keeps specific operations or processes within the company rather than assigning them to external vendors or service providers.

The following key features and advantages characterize insourcing:

  1. Internal Execution: Insourcing enables the company to leverage its workforce and infrastructure to perform the desired functions or activities. The company directly manages and controls the entire process, from planning and execution to monitoring and quality assurance.
  2. Resource Allocation: Insourcing requires allocating and utilizing the organization's internal resources, such as employees, equipment, facilities, and technology, to carry out the designated tasks. The company may need to recruit, train, and assign staff for the insourced functions.
  3. Strategic Focus: Insourcing allows companies to concentrate on their core competencies and critical operations while retaining control over crucial activities. Keeping certain functions in-house will enable organizations to align their internal capabilities with their strategic objectives and maintain higher control and coordination.
  4. Knowledge Retention: Insourcing facilitates the retention of specialized knowledge, skills, and expertise within the organization. By developing internal expertise, companies can build institutional knowledge, enhance their capabilities, and ensure continuity in the long term.
  5. Control and Oversight: By keeping operations in-house, companies have direct control over the entire process, enabling faster decision-making, better quality control, and immediate response to changes or issues.
  6. Confidentiality and Security: Insourcing can enhance data security and confidentiality, as sensitive information remains within the organization's internal systems and is subject to its security protocols.
  7. Alignment with Organizational Culture: Insourcing allows organizations to align the execution of functions with their own unique culture, values, and operating principles.

Insourcing has challenges and drawbacks, such as resource investments, limited scalability, lack of expertise, and higher fixed costs. However, resource consulting organizations can help mitigate these challenges by providing agile and cost-effective scaling of resources. Ultimately, the decision to insource or outsource functions depends on factors like cost-effectiveness, core competencies, priorities, risk management, and industry dynamics. Companies should critically evaluate these factors to determine the best approach for each function or activity.

Finding Balance With FSPs (Functional Service Providers)

An alternative approach gaining popularity within the industry is utilizing a functional service provider (FSP) model. FSPs offer specialized functional support on a project-specific basis, combining the benefits of insourcing and outsourcing. For instance, you can engage with a specialized provider for data management, biostatistics, project or program management, or monitoring to augment or elevate your trial's performance. With such functional providers, you would need to ensure that you have a strong project manager overseeing FSPs while still maintaining a laser focus on your organizational goals and values and the goals of a particular trial. As such, based on our expertise, we believe that the optimal pathway for U.S. and Canadian clinical trials (especially those in Phase 1 or Phase 2) would be to critically assess their needs and implement a combination insourced/FSP model, especially for clinical operations a key function for project success, for the following reasons:

  1. Greater Control: In-house clinical operations staff provide the biotech or pharma company with much more direct control over clinical operations, including site identification, site selection, sample tracking, drug accountability, project leadership, and monitoring. Keeping clinical operations in-house allows for greater control over study processes, timelines, and quality standards. Direct oversight enables swift decision-making and fosters a cohesive team dynamic. In addition, decisions on resource allocation can be made much faster.
  2. Enhanced Communication & Transparency: Internal teams working closely together can establish efficient communication channels, ensuring effective collaboration and alignment across different functions and outside vendors.
  3. In-depth Knowledge: In-house staff are motivated to develop a deeper understanding of the company's science, therapeutic areas, and specific study requirements, leading to more efficient study execution. CRO clinical operations staff may be assigned to multiple studies and evaluated on other key performance indicators (KPIs) that may not align with the sponsor organization's goals and values. Such dichotomies lead to a lack of focus and time to understand a study's requirements and fully problem-solve your study.
  4. Company Culture Alignment: In-house clinical operations staff are fully integrated into the company's culture, goals, and values, which results in higher levels of commitment, accountability, and alignment with organizational objectives and values. It leads to more effective problem-solving and risk-taking.
  5. Long-term Investment: Investing in in-house clinical operations is a long-term commitment to building internal expertise and capabilities and keeping the organizational and study logistical knowledge within the company, which may provide strategic advantages, study efficiencies, and cost savings over time. If outsourcing to a CRO, this knowledge could be lost when the company changes CROs for a subsequent study, CRO staff leave or are reallocated to another sponsor, and/or study or organizational learnings are not fully documented. In-house staff (or staff provided by a resource consultancy partner specifically dedicated to your organization alone) are often more engaged in the study as they have the opportunity to gain financial incentives based on their performance and are more likely to stay with a company, resulting in less staff turnover and the loss of study operational and organizational knowledge.
  6. More Focused Clinical Operation: CROs often employ a decentralized clinical operations strategy where different staff/departments perform many key study start-up activities. Many CROs' start-up activities are performed by personnel working on numerous other projects. They do not have the time to develop the detailed knowledge and understanding of your protocol and/or the science to make them effective in their initial site evaluation and/or interaction. Staff consistency throughout the start-up process is key to establishing site confidence in your study and science and building strong site relationships. Such a process should start from site identification through monitoring to ensure positive site relationships are built from day one.
  7. Greater Resource Allocation Flexibility: If key clinical operations staff are in-house, reallocating staff based on study and protocol needs and company priorities is more manageable and can be accomplished much faster. Resourcing can become problematic at a CRO, requiring change orders and repurposing clinical operations staff who may be assigned to more than one sponsor.

Before commencing early-stage trials, biotech and pharma companies should first evaluate or re-evaluate their outsourcing model. While other activities like data management and safety are essential, it is the clinical and operational execution that drives study success. It is crucial to have strong data and organizational knowledge in logistics and study execution. An in-depth understanding of the science, protocols, and logistical nuances is also necessary for successful early-phase studies. Keeping this knowledge in-house with internal clinical operations staff facilitates efficient and timely execution, study compliance, and high data quality.

Adding A "Sprinkle" Of Outsourcing To CROs  

To ensure study success when partnering with CROs, companies should hire an experienced study manager with in-depth hands on experience in the drug development process to oversee all operational services the CRO provides. The study manager will monitor the CRO's performance; conduct site visits and meetings; ensure data quality, protocol adherence, and regulatory compliance; and provide strategic operational direction. They will trust and verify all outsourced activities outlined in the scope of work (SOW), ensuring timelines and budgets are met. This oversight applies to all CRO services, as the CRO's project manager is responsible for fulfilling all tasks in the SOW.

Unfortunately, such high-level oversight and critical interaction with the CRO project manager by the company study manager often becomes more focused on day-to-day clinical operations due to staff turnover at the CRO, lack of staff expertise, and/or understanding of the study details, lack of commitment of the CRO team due to also being contracted to other sponsor studies, etc. For these reasons and those outlined above, we suggest biotech and pharma companies perform as many clinical operations tasks as possible with in-house resources.

What You Need To Bring ClinOps In-House

Bringing clinical operations in-house will require the following considerations:

  1. Infrastructure: A company needs a basic set of standard operating procedures (SOPs), work instructions (WIs), and templates to perform any clinical study. Bringing some clinical operations activities in-house will require several additional processes and procedures, depending on the extent of clinical operation tasks performed by in-house clinical resources. Such processes may include site monitoring and co-monitoring, oversight visits, clinical monitoring plan, vendor oversight, etc. Templates exist online for most of these SOPs. Alternatively, your consultant or partner resource organization can help with such templates, processes, and procedures as part of their engagement with your organization.
  1. Resources: Besides the study manager, other key clinical operations staff should include the following:
  1. Lab Sample Manager: This function is critical in early phase studies to ensure robust biomarker and pharmacokinetic (PK)/pharmacodynamic (PD) collection and tracking to minimize missed data points due to missing or lost lab samples.
  2. Drug Supply: Supply chain management is especially needed if drug supply is limited and/or delivered to patients' homes. Focusing on your study without distraction from other sponsors or commitments is critical to ensuring adequate drug inventory and timely drug delivery so no subject misses a dose.
  3. Clinical Oversight: This in-house clinical oversight could monitor some sites along with the CRO monitors and perform oversight visits to ensure CRO's CRAs' performance is optimized, site quality audits, and co-monitor visits. This individual also will manage site relationships to ensure your study remains at the top of mind at the selected sites.
  1. Trial Master File (TMF): Keeping the TMF will give the company more control, completeness, and access and ensure the quality of the TMF. Such a process is not an absolute requirement, but it does provide more control of the study documentation on a single platform by the company.
  1. Rare Diseases: Phase 1 and 2 rare disease studies have minimal patient populations and often require a global footprint to complete a study. For these studies, the number and location of the resources may be more challenging and require more strategic planning. However, the need for in-house staff may be even more relevant, as fewer subjects may be necessary for a clinical study submission, site relationships are critical, and the operational execution, drug supply/tracking, and sample tracking require more in-depth clinical operation oversight.

Level-setting Expectations: CROs Are Still Relevant

Ultimately, sponsors will likely continue partnering with CROs to deploy some or all of the required services for clinical study implementation and success. If you are looking for a one-stop shop to outsource your clinical trial needs, like shopping at a large supermarket, CROs can provide needed services. To guarantee success, a robust governance structure must be established that ensures quality, responsiveness, and a KPI structure aligned with your goals. Alternatively, insourcing and FSP can provide a more boutique experience with amplified white-glove service and quality of the deliverables. However, choosing the right CRO partner or choosing to augment/scale your internal resources with a resource consulting organization that could enable insourcing or FSP to run your clinical development is a viable differentiation step for your success especially in clinical operations.

For the many reasons discussed above, it is more critical today for biotech and pharma companies to learn and maintain as much knowledge from their early phase studies as possible. We believe this can most effectively be accomplished by hiring clinical operations staff to provide the operational excellence required to ensure robust data, protocol compliance, and study completion that meets or exceeds your company's timelines and cost expectations.

About The Authors:

Larry Blankstein, Ph.D., has worked hands-on and in leadership positions for over 35 years in clinical operations and project management at virtual, small, mid-size, and large biotech companies as well as a CRO. He is keenly aware of the challenges clinical development companies face in the transition of clinical study responsibilities and execution from in-house management and control to a total outsourcing model. Larry believes biotech and pharma can most effectively ensure optimal early-phase study execution, learnings, and control if they critically evaluate their in-house staffing needs, especially in clinical operations and study oversight. It is the balancing of the operations to keep in-house and control versus what to outsource that must be critically assessed by companies to ensure cost-effective, on-time delivery of robust data in early-phase studies.

Sophie Gorengaut is the founder and principal consultant of SuperNOVA Clinical Research. This consultancy firm provides white-glove, agile, value-driven, cost-effective, and impactful solutions, with a network to connect clients with full-service CRO and imaging capabilities. Sophie brings about 20 years of working with pharma, biotechs, and CROs to the table. With a focus on biotech companies, Sophie embodies the core principles of SuperNOVA: dedication to excellence, nurturing relationships, and advanced expertise. Sophie's project leadership skills elevate high-performing teams, enabling her to navigate complex challenges and meet critical deadlines. With her strategic vision, she empowers biotech companies to unlock their full potential and thrive in a competitive industry.