Early Phase Clinic Automation

Business Problem

Being involved in new drug production and marketing, the pharmaceutical organizations are accountable for the safety of the consumers. They face unique set of challenges during the early phase of clinical trials.

1. Recruitment of volunteers and volunteer data management is a challenge.
2. Organizations are looking for proper integration of bedside instruments and the clinical trial system. Direct data capture from the instruments is also critical.
3. Direct lab integration to ensure efficient sample processing is a challenge.
4. Accurate and integrated reporting is essential for success in the early trial phase

TechSol Solution

Techsol, in partnership with OmnicommTM, provides its clients the TrialOne solution. TrialOne is one of the best proactive eSource and early phase site automation solution that is compliant with FDA 21 CFR part 11, and supports standards such as CDISC for easy import, export and data reporting.

It is a browser-based, tablet compatible, customizable and scalable solution helps automate your early phase trial so that you can focus on making crucial decisions. The system supports end-to-end clinic automation through a reusable global library and various options for custom labelling. It provides organizations:

  • Volunteer Recruitment and Management: TrialOne provides a configurable database to capture the required data of a volunteer for a study accurately. The system has a superior search tool to ensure that the subjects are appropriately matched to the trails. It also provides a web-based recruitment form where volunteers can self-register for the trial. It facilitates smooth communication with the subjects through automatic appointment reminders, email blasts, SMS messaging and mail merge features.
  • Direct Data Capture from Devices: TrialOne ensures the bedside instruments are properly connected to the system. The system has an in-built schedule driven data collection module that. This ensures no loss of data or time lapses by capturing data directly from the devices in real-time.
  • Direct Lab Integration: TrialOne is Laboratory Information Management System (LIMS), which enables it to send lab orders and receive results directly from the lab for review and signing. This ensure one centralized location of clinical data making data management easier.
  • Quick and Accurate Reporting: TrialOne provides a centralized database that can be accessed through a browser-based interface contributing to decreased timelines and costs of monitoring. It can access data in real-time for review by experts. TrialOne offers a global library allows export of data in various formats including SAS datasets, PIPE, TAB and CSV files. The library is compliant with industry standards such as CDISC, CDASH and/or SDTM. It has built-in reports and the capability of creating custom reports that can be scheduled to run automatically. Delivery of reports to the intended recipient can also be configured.

How it is Delivered

Techsol provides complete support for your early phase trial automation requirements. We offer fully-managed regulatory compliant cloud hosting for OmnicommTM TrialOne solution. We use accelerators to deliver implementation and validation services to all our clients.

Our team of highly qualified experts provide upgradations, project management and data/system migration services. We also deliver end-user training to ensure the system is used optimally for enhanced benefits. We also provide 24*7 remote service desk and application support.