Clinical Research Operations - Are You Excelling in the Seven Critical Success Areas?

In this blog, we’re going to explore the crucial elements that site managers have to get right in order to build a successful clinical research operation.

Clinical research operations are a complex and highly regulated field where precision, efficiency, and quality are paramount.

And when IAOCR identified the need for an assessment framework for clinical research operations having consulted with opinion leaders within Pharma/Biotech, CROs, Government, Regulatory Authorities, NHS and commercial sites, NIHR and HRA to identify global best practises, the GCSA Global quality standard was born. This consultation and support now continues via a Global Advisory Board helping the continued evolution of the key areas that make up this unique Global Best Practice Standard.

Seven Pillars of Success in Clinical Research Operations

For clinical research sites to succeed, they must excel in certain key operational areas, each with its own set of expectations and challenges. We identified seven key areas where sponsors and CROs evaluate quality and performance when selecting Clinical Research sites for trials.

The seven modules that form the GCSA assessment and certification framework are:

Patient engagement
Feasibility
Study Start-up and Initiation
Study Management, Operations and Close Down
Workforce Quality
Site Business Strategy
Governance

Optimizing operational performance in these key areas will establish your site as one that can demonstrate compliant and efficient business operations, is able to deliver high quality research and deliver the critical performance outcomes that sponsors expect.

Let’s take a look at each of these key areas, examine industry requirements and expectations for success, discuss the challenges sites face and some of the measures they can adopt to achieve excellence.

Patient Engagement

A successful clinical site employs a patient-centered approach to study design and execution. Great clinical site staff and HCPs ensure high levels of communication with patients, who are provided with clear and accessible information about trials. Clear and regular communication with patients reduces common issues such as low patient awareness for upcoming trials and difficulties in maintaining long-term patient involvement in ongoing trials. Furthermore, engaging diverse patient populations, including those from underrepresented groups, requires additional sensitivity and resources.

So to meet these expectations, clinical sites should adopt a multi-faceted approach to patient engagement that includes:

Ensuring all study-related information is understandable and available in multiple languages where required.
Incorporating patient feedback where possible into draft study protocols to align with their needs and preferences.
Use of technology such as mobile apps telemedicine, and patient portals to make participation easier and more engaging.

Feasibility

From a business perspective, it is of paramount importance that a site can accurately predict its capacity to recruit and retain evaluable patients and deliver complete and timely data sets. Failure to model recruitment rates accurately leads to additional sites being required, significant additional costs for the sponsor and ultimately study delays.

A thorough review of feasibility should also critically consider patient population, the impact of inclusion/exclusion criteria on that population, the study burden of the visits and procedures determined in the protocol patient availability, travel and the mobility of the patients, site infrastructure and support, and the expertise of the investigator expertise and other site staff. Whilst feasibility assessments are often complicated by unpredictable patient recruitment numbers, underestimated resource requirements, and fluctuating regulatory landscapes, there are reliable ways to overcome these issues:

Utilizing historical data and predictive analytics tools to estimate patient population size and disease prevalence.
Engaging and consulting with all relevant stakeholders at site from the Principal Investigator, sub investigators and other site staff early in the process to gather comprehensive insights from previous experience in the therapeutical area.
Developing contingency plans to address potential challenges such as recruitment shortfalls, significant protocol amendments or unexpected regulatory hurdles.

Study Start-Up and Initiation

It’s important that studies start as they mean to go on, especially if the site is working with a sponsor who is new to them. To make a good initial impression, study start-up and initiation phases should minimise delays, expedite contract negotiations and support ethics approvals where required.

Study start-ups are often fraught with delays and bottlenecks when dealing with multiple stakeholders or when there are discrepancies in regulatory requirements across different regions. The key is in starting early and following proven strategies:

Start contract negotiations even before final protocol approval to minimize delays.
Use project management software effectively to track progress, identify bottlenecks, and manage timelines and resource effectively.
Implement standardized procedures for common tasks such as support for ethics submissions and for hosting pre study and site initiation visits to ensure the CRO or sponsor are able to conduct visits efficiently.

Study Management, Operations, and Close Down

Site managers often face challenges when overseeing the day-to-day operations of clinical trial delivery, to include site and staff management, clinical staff resourcing and scheduling and ensuring patient visit scheduling is managed effectively, managing data collection, and maintaining compliance with regulatory standards.

At the close down stage, all study-related activities must be completed, including data verification, reporting, and archiving. This phase can be particularly challenging if documentation is incomplete or data discrepancies arise.

From staff turnover to inconsistent data collection or difficulties with participant engagement, effective study management involves robust processes:

Developing Standard Operating Procedures (SOPs) for all study activities to ensure consistency and compliance.
Utilising Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS) to streamline data collection, monitor progress, and ensure data integrity.
Prepare detailed close down plans to ensure a smooth and compliant study closure.

Workforce Quality

All staff involved in clinical trials must be adequately trained, experienced, and competent in their respective roles. Continuous professional development and adherence to Good Clinical Practice (GCP) guidelines are also expected to maintain high workforce quality.

To tackle high turnover rates or gaps in expertise or skills requires a broader strategy starting with the hiring process and the way managers handle and intereact with staff. The focus areas are:

Dealing with CV fraud by designing a thorough interview process and an onboarding process will ensure you only take on the right staff.
Provide ongoing training and professional development (CPD) opportunities, including GCP certification, to keep staff updated on the latest industry standards and practices.
Regularly monitoring and assessing staff performance and provide feedback to ensure that standards are maintained.

Site Business Strategy

A well-defined business strategy includes a clear vision, competitive positioning, and a financial plan that supports all operational goals.

But how many site managers also include growth, innovation, and risk management in their plans whilst dealing with real and acute issues such as economic fluctuation changes in regulatory policies and changes in labour market and broader changes in the industry?

Without a robust business strategy, sites may face difficulties in securing funding, attracting sponsors, or differentiating themselves from competitors. To build a strong business strategy, sites should:

Conduct market research to understand industry trends, competitive landscape, and opportunities for growth.
Forge strategic partnerships with sponsors, CROs, and other stakeholders to enhance credibility and expand the site’s reach.
Develop a comprehensive financial plan that includes budgeting, forecasting, and risk management to ensure long-term sustainability.

Governance

In order to implement effective governance, site managers need to overcome the common challenges of struggling with appropriate levels of oversight and inadequate or delayed documentation. Plus, the demands of managing multiple stakeholders and ensuring that all ethical considerations are met can further strain a site’s governance capabilities.

For an organisation to maintain optimum levels of accountability, transparency, and ethical conduct to form the basis of effective governance, it needs to implement robust and comprehensive frameworks to oversee all aspects of the research process, from protocol development through to data reporting:

Establishing clear governance structures with defined roles, responsibilities, and reporting lines to ensure accountability.
Implementing regular compliance audits and reviews to ensure adherence to regulatory requirements and ethical standards.
Engaging ethics committees or Institutional Review Boards (IRBs) early in the study process to provide oversight and guidance on ethical considerations.

Transforming your clinical research operations

The GCSA process guides and supports site managers to achieve a higher standard of clinical research site operations with an internationally recognised standard that continually evolves and responds to changes in regulation and best practice in clinical research all with the support of a Global Advisory Board.

If you see an opportunity for improvement in any these areas, visit the GCSA page for information on our assessment and how it can take your clinical research operations to the next level.