Finally, an EHR solution for Clinical Trials

As in healthcare, pharmaceutical clinical research has been slow to utilize technology to automate and integrate the clinical trial process. In fact, most clinical study sites still record clinical data on paper forms and depend on transcription to deliver required information to clinical trial sponsors.

But technology solutions are now available to streamline the clinical trial process while improving regulatory compliance and patient safety. However, unless clinical data can be captured at the point of patient contact - not transcribed - the benefits of true process automation are not achievable. As long as sites must transcribe required data from patient charts and other sources, the age-old problem of quality control will remain an impediment to clinical process improvement.

EHR is the logical solution

Since an EHR is designed to document the details and outcomes of patient care, it has long been viewed as a potential solution to the transcription problem in clinical trials.

So why hasn't it happened?

Any good EHR solution can facilitate recording clinical information at the point of patient contact. But as important as clinical data capture is, it is not enough. The process of managing patients, communicating specific information and documenting/reporting disparate events according to protocol requirements must be rigidly controlled. This level of administrative control goes beyond what many healthcare providers routinely practice, so it is beyond what most EHRs are designed to support.

This isn't the only problem with EHRs as a clinical trial process management solution. Since each clinical study is somewhat unique, EHRs (and even tools designed specifically for clinical trials) need enough built-in flexibility to enable fast configurability on a trial-by-trial basis. Given the way software was developed until very recently, this level of flexibility and adaptability is beyond what most EHRs can manage.

Finally, clinical data is not generated solely at provider sites. Clinical trials now use Patient Reported outcomes (PRO) as a way to minimize expensive patient visits and maximize data quality. Since EHRs typically come into play at the point of patient contact, this rich source of crucial information are not included in the automated solution. Dealing with PRO data separately means more transcription, and the value of an automated solution is lost.

CareData's Patient Tracking and Reporting capability is the crucial missing element.

Patient Tracking and Reporting doesn't just set CareData apart in Healthcare IT. It is the solution to the problems of administrative control and Patient Reported Outcomes in clinical trials. With it, CareData's EHR application becomes a clinical trial management tool that can finally fulfill the promise of EHRs in clinical research.

Combined with CareData's patient-centric PHR, the CareData EHR supplies clinical trial sites and sponsors with the functionality required to reap the benefits of an automated process:

• Clinical data capture at the point of patient contact - without transcription.
• Direct electronic capture of laboratory test results, images, etc.
• Automatic reminders for all scheduled activity (including reports and other communication, patient appointments, etc.), alerts for required responses to dynamic events (such as adverse event reporting) and error-prevention (mistakes in data entry, etc.).
• Complete support for PROs
  • Supports controlled, compliant electronic communication between patient and provider.
  • Accurate and immediate knowledge of adverse events.
• Supports organization of any paper documents (Informed Consent, etc.) that may exist.
• Provides required security, audit trails and advanced reporting.
• Rapid configurability for different trials, protocol changes, adaptive trials, etc.

The future is now.

The CareData solution for clinical trial support is not something to dream about for the future. It is available right now. It's even fully customizable to meet the requirements of individual sponsors. And it can be deployed as a hosted or web-based solution - or you can license or purchase the code outright and adapt it however you like. The choice is yours.