Protocol And Version Control Module

Managing the study throughout its lifecycle is critical. Ensuring that everyone involved in the study has access to the latest protocol and the newest amendment has always been a challenge. VISION provides a solution – its protocol management module.

The VISION protocol management module consists of several forms. At the study level, VISION has a protocol and amendment form that allows the latest protocol to be uploaded into VISION by simply selecting the file and saving it to the system (see screen shot below). The Amendments section also allows a file to be uploaded for each amendment as well as information that would be useful in quickly understanding the changes. After the first amendment is saved, an additional row appears for subsequent amendments.

Ensuring that everyone has access to the amendment and protocol doesn’t only mean, make it available in a central location, it also means, ensuring there is an audit trail of when it was made available, who made it available and who has viewed it. VISION keeps a full audit trail of these events.

In addition to ensuring the protocol and amendments are available, it is important to track any protocol deviations that have occurred. VISION enables this by providing deviation forms at the patient, site and study level. Below is an example of a study level deviation form.

All deviation forms are automatically masked to ensure that masked staff is not accidentally unveiled. Protocol deviations entered by project managers, monitors, and treatment dispensers as well as other roles that are unmasked are automatically masked from everyone else participating in the study. If any of these roles chooses to share the deviation with others, clicking the “share with all” check box prior to saving the deviation will unmask it.

Below is an example of a patient level deviation form that shows a masked deviation as well as 3 test deviations that were either entered by the role viewing them or shared with all.

A full audit trail of who entered the data is available. Note: If a role is unable to see a particular deviation, they will not be able to see the audit trail for that deviation either.

Prelude Dynamics Named in New GIA Report on E-Clinical Trial Technology Driven by Emphasis on Operational Excellence

SAN JOSE, CA (PRWEB) – February 4, 2015 – Demand for e-Clinical trial technologies is on the rise, spurred by the mounting pressure on biotech and pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) to accelerate the processes for clinical studies, regulatory approval, and commercialization of drugs. Stringent regulations mandating standardization of clinical study data and the acceptance of electronic submissions of clinical data by regulatory authorities are driving the need for advanced, user-friendly on-site data collection tools and eClinical systems. The growing trend towards globalization and outsourcing of the drug development process, coupled with the increasing complexity of Phase IV or post-marketing studies, are providing opportunities for clinical trial management solutions. Cloud computing is rapidly growing in popularity as a preferred model for delivery of e-clinical trial solutions. Cost advantages, flexibility, and functionality are key benefits driving customer acceptance of cloud solutions. Open source technologies are emerging into a preferred platform, given their cost advantages and interoperability benefits over proprietary platforms.

As stated by the new market research report on E-Clinical Trial Technologies, North America remains the most prominent market worldwide, supported by the strict legislative and regulatory atmosphere, and escalating clinical trial expenditure. Asia-Pacific ranks as the fastest growing market with a CAGR of 13.6% over the analysis period. Developing economies with large heterogeneous patient pools and high diseases prevalence are attractive locations for conducting clinical trials. Electronic Data Capture represents the largest technology sector, supported by the rapid replacement of the traditional paper based systems. Despite numerous time-saving and cost advantages, EDC adoption remains relatively low in Phase I clinical trials due to high purchase and implementation costs. Phase III clinical trials provide the bulk of sales revenue of EDC solutions. Tablet-based EDCs are gaining in popularity due to the portability benefits offered.

The research report titled “E-Clinical Trial Technologies: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, growth drivers, recent mergers and acquisitions, strategic industry activities, and profiles of major and niche companies worldwide. The research report provides market estimates and projections in US$ Million for major geographic markets including the United States, Canada, Europe, Asia-Pacific (including Japan), and Rest of World. The global market is analyzed by major E-Clinical Trial Technologies, namely Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Patient Reported Outcome (ePRO), and Randomization and Trial Supply Management (RTSM) Systems. The EDC segment is further analyzed by Clinical Trial Phase (Phase I to Phase IV), and CTMS segment by Delivery Mode (Web-based CTMS, Cloud-based CTMS, and On-Premise CTMS).