The study sponsor needed:

1. Selection and recruitment of Primary and Secondary care sites - experienced & research naïve
2. Accurate feasibility
3. On-time study delivery
4. Patient recruitment support
5. Effective cost management

Research naïve sites

• Untapped patient pools
• Increased Prinicipal Investigator focus
• Maximised site reach

Bespoke patient communication:

• Increase response rate due to telephone calls by trained staff

Enhanced patient experience:

• Provision of domiciliary visits
• Highly trained research nurses
• Weekend and evening clinics

Teamwork:

• Flexible nurse cover
• Study facilitators
• On-site mentoring of research nurses

21% more patients recruited in CHASE clinical sites vs non-CHASE clinical sites*

Average number of days to close a data query – CHASE clinical sites 6 days, non-CHASE clinical sites 10 days*

Average time to enter data into the Electronic Case Report Form after a patient visit – CHASE clinical sites 0.6 days (same day), non-CHASE clinical sites 3 days*

* data on file

In 2018, a global pharmaceutical company / study sponsor teamed up with CHASE clinical to support with feasibility for a new, innovative real-world evidence study they were planning.

They needed support with identification of:

1. Suitable sites
2. Identification of patients who met the protocol inclusion criteria
3. Protocol specific searches to determine accurate numbers of suitable patients

The study sponsor required the feasibility to be delivered across approximately 24 sites within a 2-month period. The study involved the use of smart technology with the addition of an integrated Bluetooth device linked to a smart phone to measure subject compliance.

1. Utilised our network to identify appropriate sites to follow up by email, phone or face to face communication
2. The study sponsor asked CHASE clinical to suggest 8 to 12 of the best overall recruitment sites
3. Provided confidentiality agreements to each site and shared the protocol
4. Principal Investigator site visits were arranged to discuss the study and answer questions on how the study would run
5. Protocol specific searches were developed for EMIS, System One and Vision clinical systems
6. The searches were run at each site to determine the possible patient population
7. Results were then shared and the sites were asked to clean the lists to remove unsuitable patients
8. Post cleaning CHASE clinical asked the sites to confirm the numbers and determined realistic local targets
9. CHASE clinical then applied historical, demographic recruitment trends to these numbers to create a realistic target of patients at each site
10. This data and other relevant site information was captured in a feasibility template and delivered to the sponsor ahead of contracted timelines

Sites were selected based on:

1. Practise population
2. Room availability (6 days per week ideally)
3. Feasibility of sites to run early morning/late evening & Saturday clinics to increase the chances of recruiting patients in full time employment
4. Highly engaged Principal Investigators with large patient populations, good room availability and access
5. Use of EMIS, System One and Vision clinical systems to extract patients
6. Agreement to use domiciliary visits to speed recruitment of the less mobile patients

CHASE clinical engaged 24 GP sites within 2 months

• Within each site, CHASE clinical arranged a face to face visit and ran searches
• Approximately 1,660 patients identified as fulfilling the protocol requirements
• CHASE clinical calculated a potential recruitment pool of 331 patients
• CHASE clinical provided the sponsor with site recommendations, timelines and recruitment rates
• CHASE clinical also provided the sponsor with a contingency plan based around the unknowns of smartphone ownership and data contracts

How will this support your clinical trial to recruit the correct patients?

1. CHASE clinical provide accurate feasibility increasing the opportunity to recruit to plan and to identity gaps earlier
2. By deploying CHASE clinical flexible and cost effective nurse resources
3. CHASE clinical deploy experienced research nurses at sites to deliver faster patient recruitment with improved patient retention

CHASE clinical services include:

• Study Feasibility
• Site Selection
• Patient Recruitment
• High Governance Standards
• Data Quality
• Principle Investigator(s) Support
• Expert Project Management