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Site Monitoring Reinvented Part 1

Unified Microsoft Office-Smart CTMS, MVR

CTMS and MVR, Across the Great Divide
As anyone in pharma knows, our industry is undergoing major change; clinical trials are rapidly evolving and eClinical technologies are becoming more sophisticated by the day. Meanwhile site monitoring continues to be one of the most critical, costly, and labor-intensive activities in a clinical trial. Looking for a better way to address this, many organizations have made the switch from conventional CTMS to the "Microsoft Office-Smart" model.

Adopters experienced immediate improvements in a variety of clinical trial management areas including site monitoring. With these benefits, now is an opportune time for organizations to consider the way site monitoring is handled and how CTMS can improve efficiencies and lower costs.

Unified Microsoft Office-Smart CTMS, MVR 
The Office-Smart CTMS creates a highly connected clinical trial environment and automates activities − effectively reinventing the way site monitoring is done. This provides many important advantages by leveraging the widely used Microsoft suite (Outlook, Excel, Word, and SharePoint). It is a CTMS that is highly evolved, highly automated, and highly connected.

In reinventing site monitoring, what used to be "wishes" have become reality:        

  • Clinical site monitors are not required to log into multiple systems or re-enter the same information over and over again.
  • No monitor is forced to transcribe data from a site visit report and into a disconnected eClinical system.  
  • Monitors are able to easily switch between working securely offline and online – without sacrificing automation or system performance. (For more on this, see Part 2 of this blog.)

Many Questions, One Answer
If you're experienced in CTMS, right about now you're probably asking some good questions such as:  How is this possible without a relational database structure to provide context?  Without study, region, and site hierarchy how valuable is monitoring information?  How can data coming from several different sources be consolidated for reporting?

The answer to each of these questions is found in the Office-Smart CTMS. The system gives you a secure and constant link between the core CTMS and SharePoint. You have synchronization among Microsoft, SharePoint, and the other Office tools, making for a uniquely powerful solution. All of the important operational study data like site dates, statuses, and milestones is controlled through your CTMS.

Compare this with the conventional model in which information is coming from multiple data sources, internal and external, and then consolidated into CTMS. One of the biggest complaints of sponsors and CROs is the difficulty in getting critical information out of those systems and into decision makers' hands. Other sore points are reports, dashboards, and scorecards; users must either be trained to access the CTMS, or worse yet, additional staffing must be hired to perform these functions!

Familiar Tools  
BioClinica recommends allowing all study team members to continue using familiar Microsoft tools and a friendly role-based interface. This solution can be extended to any team member whether they need access to select data or broader access to make trial management decisions.

Accessibility is especially important to site monitors who frequently travel from site-to-site as well as organizations that employ a mixed monitoring model where a combination of internal and external resources is used. We love hearing feedback and site monitors often speak up first and the loudest. Here's what tops their list of favorite tools:

  • Outlook for calendars, contacts, and action items;
  • Word for site visit reports; and
  • SharePoint for the document review and approval process − all linked back to automatically update CTMS at the appropriate status triggers!

Top 3 Advantages of an Office-Smart CTMS
Aside from site monitors, the full study team benefits from using an Office-Smart CTMS. This holds true whether they work for the sponsor or CRO or if they are an outsourcing specialist involved in monitor tracking, administrative or performance reporting.

While it's hard to narrow down, here are the top three advantages of an Office-Smart CTMS based on feedback from recent implementations:

  1. Efficiency
    Automation decreases, or completely eliminates, duplicate data entry
    • Site visit reports are automatically populated with relevant CTMS information
    • An organization can continue using its own visit report templates, if desired
    • Monitors can work securely offline without needing to later transcribe data
    • Once approved, site visit report information is automatically uploaded into the CTMS
  2. Accuracy
    An Office-Smart CTMS reduces errors with user-facing data entry controls
    • Monitors capture data in a central place, eliminating redundancy and risk of transcription errors
    • Visibility into data changes is provided, both for regulatory compliance and internal auditing and performance tracking purposes
    • SharePoint document controls, such as check-in/check-out and version history, ensure proper document control and handling
  3. User Adoption
    Study personnel continue working with familiar Microsoft tools and templates
    • No need to train site monitors to use the CTMS
    • Leverage existing Microsoft products and benefit from having a secure interface for CTMS data
    • A low learning curve, the Office-Smart model incurs minimal training and support costs
    • Consolidated information about monitoring activities provides actionable performance tracking

BioClinica's Office-Smart CTMS, OnPoint, is presently in use by mid- and large-size pharma and CROs on global clinical trials in all therapeutic areas, as well as by progressive start-ups and rapidly expanding research organizations who want a flexible solution that will grow with them.

With cost, efficiency, accuracy, and usability advantages of an Office-Smart CTMS, is it time to take a fresh look at your CTMS and site monitoring tools?

If you would like to know more about OnPoint and how automation within a highly connected trial environment can benefit your organization, give me a call at (206) 769-7886 or email me at jeremiah.rehm@bioclinica.com, or submit an online Contact BioClinica request. Ask to see OnPoint and the MVR for yourself in a demonstration!

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