StudyProtocol

StudyProtocol is a software suite designed to accelerate various aspects of clinical trial management. According to the vendor, it is suitable for clinical research professionals, pharmaceutical companies, contract research organizations (CROs), academic research institutions, and medical device companies of all sizes. Its aim is to bridge the gap between technology, science, and patients in order to advance medical innovation.

Key Features

Unlimited studies: According to the vendor, StudyProtocol allows users to set up any protocol for any condition, providing flexibility in managing multiple studies simultaneously. Users can create and manage an unlimited number of studies within the platform, which is said to streamline their management processes.

Operational efficiency: The vendor claims that StudyProtocol aims to optimize trial processes, streamline workflows, and reduce the daily administrative burden. The platform provides tools and features that are said to enhance operational efficiency, allowing users to focus more on the research itself and improve overall trial management.

Invoicing & Payments: StudyProtocol reportedly offers seamless invoicing and fast online payment capabilities. Users can easily send invoices, set up autopay, and manage subject payments within the platform, simplifying the financial aspects of clinical trials.

Data integrity: According to the vendor, StudyProtocol prioritizes maintaining uncompromised data integrity throughout the clinical trial process. The platform includes validation, quality checks, and audit trails to ensure trustworthy clinical trial data, helping researchers maintain the accuracy and reliability of their study data.

21 CFR Part 11 Compliance: The vendor states that StudyProtocol is purpose-built to meet the requirements of 21 CFR Part 11. This compliance is said to ensure data authenticity, confidentiality, and accessibility throughout the study, providing researchers with secure and compliant data management.

Protocol configuration: According to the vendor, StudyProtocol allows users to keep up with the latest protocol versions, reducing deviations and increasing overall protocol adherence. By managing protocol versions effectively, researchers can ensure consistency and accuracy in their studies.

Visits and appointments: StudyProtocol reportedly provides a scheduling feature to organize and manage study visits. Users can schedule visits and ensure that the necessary procedures are implemented on time, minimizing protocol deviations and maintaining study integrity.

Invoice creation: The vendor claims that StudyProtocol offers a comprehensive solution for clinical trial accounting. Users can negotiate budgets, simplify invoicing, and track payments at both the sponsor and research site levels, streamlining financial processes and ensuring effective financial management throughout the trial.

Subject scheduling: According to the vendor, StudyProtocol includes a feature to schedule subjects' visits within the appropriate tolerance window. Users can ensure that visits are scheduled in a timely manner, avoiding protocol deviations and maintaining study timelines.

Informed consent forms: StudyProtocol reportedly provides a feature to manage informed consent forms (ICFs). Users can easily manage ICFs and receive system alerts for re-consents, reducing deviations and ensuring compliance, thereby maintaining study integrity and mitigating risks related to informed consent.