Pharma Consulting Group | Viedoc™

Timely information is critical to successful clinical trial management. The need to stay on top of what is happening with the clinical trial instead of waiting weeks for information is vital.

Viedoc™ is used worldwide to ensure a trial sponsor has up to the minute access to information, including:

  • Patient recruitment and enrolment
  • Query status
  • Data entry status
  • Document sharing
  • Source Data verification
  • Monitoring visit reports

Viedoc is a web-based application. It offers a faster, more efficient way to handle the data processing needed for trials. The only requirement is a web browser with internet connection. It is extremely easy to use and training takes approximately 30 minutes.

Viedoc™ features include

  • Focus on the user and easing their daily work
  • Regulatory compliant
  • Available internationally with support for multiple languages and geographically distributed trials
  • Make data easy to access and complete, integrated with external data sources such as labs, etc.
  • Save time and money

Focus on the User. Viedoc is intuitive, user-friendly and powerful. This web-based software enables efficient sharing of information, project management and monitoring of study activities and sites. It has world class functionality that is appreciated by sponsors, investigators and study nurses. The design makes it easy to use and learn, and training is held at investigator meetings, web casts and during pre-study visits.

Regulatory Compliance. From the beginning, Viedoc was developed with focus on ensuring that it complies with all relevant regulations in North America, Europe and Japan, including FDA 21 CFR Part 11, CSUCI, ICH GCP, CDISC, HIPAA, PuL and EU Annex 11.

How Viedoc™ Works?

The Viedoc application is project specific. It will be designed according to the clinical study protocol and the CRF and is set-up for access by the study organisation.

Enter data at any time. Because Viedoc is available 24 hours a day, tasks such as data entry, trial management, queries, logic checks and data downloads into SAS datasets can be done at any time.

View real time information. The study site enters the data into Viedoc and up-to-date information regarding the study progress is immediately published (e.g. patient recruitment and enrolment, query status and data entry status).

Validate and query directly in the system. Clinical research managers and associates are able to monitor the project and study site performance while the study is running. They can send queries to further clarify entered data if necessary.

Detect potential issues earlier. With Viedoc, clinical data is available for review earlier in the study. Events, such as patient safety issues, concerns for example adverse events or data trends, can be evaluated as they occur. This knowledge enables more timely and accurate decisions about patient safety issues.

Early screening of clinical data. Availability of the clinical data during the study facilitates faster and better decision making regarding the protocol and the progression of the entire trial. This earlier screening of clinical data and trial information permits better and more proactive project management resulting in a better-conducted and more efficient trial.

All activities are logged and monitoring reports are available. Data, issues queries and approval of the CRF pages are done by the CRA. Monitoring reports are built into the system using the activities logs which allows all documentation for a project to be stored and accessed by the project manager in one application. This reduces burdensome paperwork. Study site information can also be entered into the system, e.g. staff, CVs, contact information and feasibility information (capacity, patients, equipment).

Minimize costs associated with data monitoring. Using Viedoc reduces travel costs, as well as the duration and frequency of on-site visits. Monitors minimize travel and maximize effectiveness while on site. In addition, daily data monitoring increases the quality of data.

Support is available. Viedoc system support is available during office hours for the entire project. Senior project managers are available for assistance, lessening management load and ensuring that requirements are addressed accurately and efficiently.