Phase I and Early Phase II studies (IIa) generally have the aim of establishing the safety, tolerability and pharmacokinetics of one or more doses and formulations. Traditionally many of these studies have been conducted at a single site so that the randomization, dosing, dispensing, and progression between successive cohorts could be tightly managed. However, it can be difficult to recruit the right patients from a single population. This means that early phase studies are becoming multi-site and global to enable competitive recruitment, making potentially complex cohort management and supplies tracking more difficult and risky to manage manually. Randomization and Trial Supply Management (RTSM) services, enabled by IRT (Interactive Response Technology), can deliver data management and workflow support to manage cohorts and supplies across multiple sites.
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ClinPhone® RTSM for Early Phase
Early phase (I/IIa) studies require systems and processes that are fast, flexible, and cost-effective while coping with complex study designs. The unique challenges of safety focused studies include:
- Set up time required can be very fast with timelines often determined only by availability of IRB (Institutional Review Board) to review protocols
- Studies often need very rapid design changes as information is learned about a new drug candidate, new formulations become available and dose-ranges are established
- Extending trials to multiple sites to increase patient recruitment makes potentially complex cohort management and supplies tracking more difficult and risky to manage manually
- Relatively small study budgets for technology
ClinPhone® RTSM for Early Phase is a service specifically tailored to address these challenges by delivering:
- Rapid system configuration through prototyping - system typically delivered in 4 to 8 weeks, can be as little as 2 weeks, subject to study requirements
- Ability to apply rapid design changes as protocols develop
- Experience and tools to implement complex study designs quickly:
- Complex cohort management
- Complex randomization and dosing schemes including dynamic randomization to maximize balance across small patient populations
- Adaptive trial designs
- Cost-effective implementations and operations
Study Management in ClinPhone RTSM
Early Phase Services
More of What You Need for a Stronger Start in Phase I. Your journey from new molecule to new medicine starts with appropriate subjects, world class facilities, and more timely results. PAREXEL® provides comprehensive early phase testing services through our own hospital-based clinical units on three continents.
Customer Care Services
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).