The First Ever Site-less CRO Model
Center Point’s Site-less CRO model enables clinical studies and research to be conducted at an unprecedented scale and scope as well as in a more time and cost efficient manner than traditional models.
The Site-less CRO model combines advanced communication tools with the personal service of specially trained pharmacists to empower study sponsors to adapt to the new world of patient-centric and direct-to-patient healthcare.
The Site-less CRO model de-risks the clinical trial process, increases quality, and ensures robust data. These deliverables enable a shorter path to regulatory and commercialization success.
- What are the benefits of using a Site-Less CRO rather than a traditional CRO design?
Current clinical trial models are built around geographical clinical sites, and up to 70% of trial patients may not have convenient access to them. Moreover, clinical trial sites vary greatly in speed of communication, cost to recruit and manage patients, and quality of outcomes delivered. The numbers speak for themselves. Clinical trials currently cost approximately $50 billion annually, take six to nine years on average to complete, and may account for almost 40% of total therapy costs
Center Point Clinical Services’ Site-less CRO model helps solve the current problems associated with traditional models including protocol violations, record-keeping inaccuracies and omissions, informed consent form challenges and inefficiencies and adverse events and safety reporting failure – all which lead to increased costs and longer trials.
- Reduce the risk of your clinical trial not achieving success.
- Test drugs and devices better.
- Rescue failing clinical trials.
Center Point’s Site-less CRO model uses technology and pharmacist engagement for electronic recruitment and enrollment, along with in-country support as well as direct-to-patient clinical medicine and device distribution. Center Point’s Site-less CRO and CTRP services also provides technology for data aggregation and a ProRA (Proactive Risk Assessment) data engine. The Site-less CRO model unbundles services, increases quality, decreases costs, reduces response time and allows proactive and real-time analysis and action. In addition, it improves patient experiences and engagement, enhances quality of outcomes and reduces clinical trial costs.
- Is the Site-Less CRO Model Good For All Therapeutic Areas?
The following types of studies are best suited to benefit from the Site-less CRO model:
- Therapies that do not require office visits/assessments or can be done remotely
- Studies recruiting patients in remote geographical areas or where transportation is a challenge (i.e., those with neurocognitive and neurodegenerative disease, Huntington’s disease, ALS)
- Studies that require patients to transport large amounts of cold chain medicines
- Studies that require a high volume of office visits
- Studies enrolling complex patient types (i.e., orphan rare disease, geriatric, pediatric)
- Studies that will continue for a long time
- How Does it Work?
The Site-less CRO model leverages the power of the web as a communication and enterprise tool. Center Point’s CTRP® service coordinates patient communication using a technology platform that facilitates recruitment and enrollment, electronic data collection (EDC), safety and video conferencing, Direct-to-Patient (DtP) clinical supplies distribution, data aggregation, analysis, and action in real-time. Electronic medical records (EMR) are also used to systematically collect data where appropriate.
Below are a list of the daily and practical deliverables of Center Point’s site-less CRO:
- Provides real-time communication to sponsor and steering committee
- Addresses challenges to recruitment, enrollment, and informed consent
- Solves logistical support issues for medicines and distribution
- Confirmation and validation of outcomes and adverse events reporting
- Reduces misunderstanding of outcomes and adverse events definitions
- Enables review of data in real time as per protocol design
- Monitors for outliers in data and data rates
- How Can a Site-less CRO Reduce Recruitment Time?
Center Point’s site-less CRO model reduces site recruitment time by reaching out to physicians, pharmacists and patients through multiple web-based sites, social media and email. As many as 1 to 10,000 patients can be instantly registered, as needed. Investigators and/or monitors are qualified and recruited using a simple web-based form.
Patients are enrolled using the web, phone, or with the help of medical office or pharmacy staff. Thereafter, a clinical supplies management company distributes the assigned drugs using a courier service such as UPS or FedEx.