Once treatment is near or even through the approval process, the next step is to demonstrate long-term safety, efficacy and value to gain effective market access and successful commercialization. Late phase clinical trials and observational research studies can involve enrolment and management of hundreds of sites and tens of thousands of patients, with increasing global reach. Monitoring of enrolment, dispensing, and supplies can be challenging to manage manually. Randomization and Trial Supply Management (RTSM) services provide expertise and IRT (Interactive Response Technology) to enable effective management and real-time reporting of patient progress, medication assignments and supplies. We look at the challenges in Peri/Post Approval studies as well as the services that we can offer.
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ClinPhone® RTSM for Peri/Post-Approval
Late phase (IIIb/IV) studies, otherwise known as peri-approval and post-marketing studies, require operations and technology that can support large global study sizes. The unique challenges of peri/post-approval studies include:
Increasing size (up to 100’s of sites and 10,000’s of patients) and data complexity
Site personnel may have limited clinical trials experience
Global studies introduce language barriers -sites are often not English-speaking
Sites have limited storage for supplies
Maximizing compliance in patient reported outcomes
ClinPhone® RTSM for Peri/Post-Approval is a service specifically tailored to address these challenges by delivering:
Scalability to manage large volumes of sites and patients
Simplicity of site user interface to aid those less experienced in clinical trials
Translation of IVR and IWR into local languages
Management of supplies to maximize efficient use of available drugs
Rapid system configuration and changes makes systems cost-effective
Solid integrations with ePRO/eCOA (electronic Patient Reported Outcomes/electronic Clinical Outcome Assessments) systems
Patient Management in ClinPhone RTSM
Late-Stage Clinical Operations
Electronic Data Capture
The DataLabs® EDC (Electronic Data Capture) solution is uniquely focused on simplifying workflows and delivering superior user experiences. Its advanced EDC features help streamline the entire process starting from study design all the way to collection, management and reporting of clinical trial data.
Electronic Clinical Outcome Assessments (eCOA)
Clinical Outcome Assessments (COAs) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit. COA types include ePRO (electronic Patient Reported Outcomes).