Our dedicated Clinical Research Associates and CRAs and CMAs monitor studies worldwide. Each CRA focuses on a single therapy area, so they have deep knowledge of the patients, investigative sites and specific challenges involved. All Clinical Trial Monitoring team members receive ongoing training to ensure they are completely up-to-date with current legislation, techniques and technologies. They are supported by our innovative Global Clinical Operations Management (GCOM) and Central Monitoring groups.
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92+
investigative studies have services provided by our central monitoring group
Thorough training and support are vital for CRAs at all levels. We provide training via the CTI, to ensure our CRAs are always up-to-date with new techniques and technologies, and familiar with any changes in legislature. Over time, our CRAs build a strong rapport with site staff and develop a deep understanding of the challenges sites face.
Our Central Monitoring group supports sites and patients, overseeing the running of studies and directing strategy throughout the clinical trial process. The group acts as a bridge between the Site Start Up team and therapy area unit, playing a central role in developing and trialing new processes, and driving solutions around data-focused monitoring, as well as predicting any issues that may arise.
Via the GCOM group, we provide data analysis to improve processes, increase efficiency and add value to deliver enhanced quality and compliance metrics to identify areas for improvement, such as changes to SOPs, tools and systems, and training needs.
The GCOM also oversees the Global Resource Management (GRM) tool, which tracks staff assignments and allocations, providing direction around staffing needs. In addition, the GCOM represents the clinical perspective in corporate initiatives, such as strategic data monitoring and staff training.
FSP Model
We offer our global clinical monitoring capabilities in either a full service or FSP model. Our Clinical FSP Monitoring Group engages a hands-on partnering approach that emphasizes collaboration and communication between the assigned CRAs, investigative sites, cross-functional teams, line management and customers. From site assessment and qualification to study close-out, our commitment to success starts with the first conversation.
Our agility and flexibility are critical for study uniqueness, and are paired with careful management of site interactions and strong therapeutic experience across all levels to ensure consistent delivery and solutions by our teams.
Quality and oversight are elevated, with a mindset focused on providing the specific clinical requirements for the individual study, with adaptable governance and an evolved line management structure.
Integrating the right talent with measureable outcomes, high quality and open communication with the customer’s direction provides a gateway to site engagement for patient focus and meaningful outcomes.
Case Study
Background: We have partnered with a large global pharmaceutical company on their early development portfolio for the past five years. This partnership has expanded to incorporate small studies. As with all early development studies, quick start up and flexibility are paramount. Processes need to be more streamlined in the development and small study stages than in Phases II-IV.
Solution: We have developed tailored budget and delivery approaches in response to these unique needs. We have also created a dedicated core team with extensive experience in running smaller early phase health volunteer and patient studies in a broad range of therapeutic areas.
The team has the ability to quickly flex between providing both full service study management and limited services support.
Results: By having a dedicated team, we are able to focus on ensuring the priority of small studies versus larger Phase III-IV studies, enabling flexible resourcing, including the ability to shift knowledgeable resources among studies at the sponsor’s request while maintaining quality. This allows for the sponsor to quickly and effectively substantiate go/no-go decisions, developing sponsor-specific processes and templates that all members of the team become experts on, and immediate Site Start Up. An award notice immediately triggers Project Management resource assignment, with Site Start Up and Clinical Monitoring resources typically aligned to the project within 1-2 weeks (depending on urgency).
This well-established solution results in increased accuracy and efficiency of budget forecasting, reduced time for site identification and the number of on-time approvals for IP release, maintenance of operational consistency across studies due to a dedicated core team, creation of study-specific work order templates to facilitate rapid execution, and an increase in the volume of work and geographies included in the partnership.
Our vision of a strategic partnership is built on open communication and shared expectations that allow us to customize our solution to your specific needs.
The key objectives of a strategic partnership include working together as true partners and operating as a fully integrated team with shared goals, collaboratively driving toward continuous improvement in the areas of quality, innovation and efficiency, and capitalizing on best practices and lessons learned.
Based on our extensive experience and success in establishing, managing and evolving functional partnerships, the following factors form elements of our transition planning that we know are critical to the success of the partnership:
Planning. Understanding the customer’s trial monitoring organization, goals and objectives, as well as identifying key milestones to build the transition plan and ensure continued success.
Launch. Three factors that are especially important to successful start up are the timing of the partnership launch meeting, which should be within two weeks of award, the setting of a timetable to review project pipelines, and re-establishing the objectives of the relationship in clear, direct terms that can be communicated to all team members.
Metrics. We want to ensure that quality and timeline metrics are well defined and understood by all partnership members. Both organizations need to be clear on timeline expectations, the responsibilities of each partner, and the definition of quality. Early agreement on key performance indicators (KPIs) will facilitate focused and productive discussions.
Governance Structures. This predefined structure creates escalation channels to resolve business and operational issues and ensure the proper communication of objectives consistently through both organizations.
Establish Communication Opportunities Between Core Teams. The quality of the relationships built within this partnership drives success. We recognize the importance of, and are committed to, establishing positive working relationships with the customer to promote honest, open dialogue and allow for the highest quality service delivery.
Success is seen in:
- The customer’s internal teams’ confidence in the model
- The partnership working seamlessly with shared goals and deliverables
- Delivery against KPIs and the customer's business outcomes
We draft a formal Implementation plan, which we refine collaboratively with our customer in the initial stages of this partnership expansion kick-off. The plan addresses a comprehensive range of topics, including, but not limited to:
Management and Governance. Integrating our management team with yours, ensuring seamless communication, and promoting effective teamwork, including defining executive operations and project-level leadership groups, SLAs and KPIs, communications and meeting cadences, and drafting Executive and Operations Management Committee charters.
Resourcing. Forecasting needs and setting strategy, including:
- Defining process for reviewing staffing levels, including frequency and detail of forecasts
- Identifying resources in scope for transfer to us
- Identifying candidate pool to mitigate any risk for non-transition
- Retention and integration strategy
Operational Standards and Practices. This framework enables resources to work within the applicable SOPs and on the customer’s systems, including:
- Drafting an operations plan document outline
- Communication and management tools
- Management is responsible, accountable, consulted and informed (RACI)
- Training and onboarding
- Defining performance and compliance metrics
Our SRG Monitoring Group engages a hands-on partnering approach that emphasizes collaboration and communication between the assigned CRAs, investigative sites, cross-functional teams, line management and customers. From site assessment and qualification to study close-out, our commitment to success starts with the first conversation.
Our agility and flexibility are critical for study uniqueness, and are paired with careful management of site interactions and strong therapeutic experience across all levels to ensure consistent delivery and solutions by our teams.
Quality and oversight are elevated, with a mindset focused on providing the specific clinical requirements for the individual study, with adaptable governance and an evolved line management structure.
Integrating the right talent with measureable outcomes, high quality and open communication with the customer’s direction provides a gateway to site engagement for patient focus and meaningful outcomes.
