Clinical Trials for Medical Practices and Physicians

Recruitment, Management, and Reporting Automation

Our MedicsCloud Suite has a number of innovative features including an ability to comprehensively automate the complicated world of clinical trials for investigators (physicians) and practices (sites).

Through its unique data-driven patient approach, the MedicsCloud EHR not only has the ability to match relevant clinical trials to clinical outcomes and metrics, but can also identify patients (patient recruitment) who might benefit from a particular clinical trial based on diagnosis and any specific criteria related to the trial’s parameters.

For those practices interested in being considered for a study, MedicsCloud EHR supports continuous monitoring, data gathering, protocol design, and execution. The system minimizes protocol failure while it adds to / increases the revenue stream in an ambulatory setting based upon funds that are generally available from Sponsors (pharmaceutical companies) when their clinical trials are prescribed.

An integrated Source Document Component for protocol customization is available in the MedicsCloud EHR. Components such as the Electronic Case Report Form (eCRF) and the Clinical Trials Management System (CTMS) with milestone reporting are also available.

The system’s automated clinical trial data collecting and management capabilities create a truly simplified method in evaluating your patient population group by zeroing in on patients who may be eligible for clinical trials. Recruitment potential by your practice is greatly enhanced through these tools.

How Does Our Practice Get Started?

• With the historical clinical data gleaned from the EHR or its Practice Management component, the practice is provided with trend graphs showing a feasibility assessment of the number of patients who meet the criteria, retrospectively for five years.
• Based on the initial acceptance from the Sponsor or CRO, ADS will coordinate with the practice to complete a Clinical Trial Alert (CTA / see next section) and site selection questionnaire.

Based on the protocol’s criteria and historical data in the MedicsCloud EHR, the system’s Clinical Trial Alert (CTA) mechanism is enabled to determine suitable patients.

• The system’s CTA is customized per-site / per-protocol.
• As mentioned, the CTA helps in proactively gauging the patient’s interest in participating in clinical trials.
• A list of patients is produced consisting of those who match the protocol based on inclusion and exclusion criteria.

Patient Identification is based on proactive data.

• As soon as the EHR determines that a patient’s data meets the selected trial criteria (typically during the encounter), the system’s CTA mechanism prompts the physician about an available trial. The physician can then verify the patient’s eligibility, discuss the trial, determine patient interest, and obtain a consent. A secure messaging enhancement is enabled to the trial’s coordinator.
• The CTA mechanism operates based on the EHR being able to recognize the specific trial, the clinical decision support system (CDSS), and its communications capabilities.
• Next, a patient-specific CTA window appears onscreen from which the physician can select the correct option for that patient:
• The patient meets the study criteria and is interested (referral order)
• The patient does not meet the study criteria at this time (not eligible order)
• The patient meets the study criteria but is not interested at this time (not interested order)

Selecting Option 1 automatically transmits a secure message from within the EHR to the Trial Coordinator. This message includes a link to the patient’s electronic medical chart and a Consent Workflow to confirm the patient’s permission to review the chart to further determine eligibility.

Based on the Consent Workflow, the coordinator has tasks set to call the patient after chart review, as well as a follow-up processes for potentially eligible patients for further evaluation.

A referral order is printed along with discharge instructions containing general trial-related information at checkout. Post-visit instructions advise the patient to expect contact from the trial’s coordinator within two weeks regarding their eligibility. It also contains a reminder that the patient is not obligated should they decide not to proceed.

The presence of a referral order intelligently prevents the CTA mechanism from triggering future contact with the patient for the same trial.

EASY DATA COLLECTION

MedicsCloud EHR will keep track of physicians contributing to trial recruitment as well as physician-generated referrals and enrollment rates. Descriptive analyses can be generated by the practice showing the physicians participating in recruitment, and their monthly recruitment rates.

Investigators / Physicians: Why the MedicsCloud EHR as your Clinical Trials Automation Tool?

Because the system’s ability to identify and recruit patients is so exceptional, the results are equally so in terms of:

• Having more options in providing patient care with new medications
• Deriving an added, potentially lucrative revenue that can be obtained through clinical trials

Why ADS as your Clinical Trials Automation Vendor?

As a well-established (since 1977) trusted partner, ADS’ Clinical Software Research Division acts as the clinical trials conduit to our clients, and to Sponsor / CRO partners. ADS bridges time and expense gaps in study site set-up by leveraging the exceptional technology in our MedicsCloud Suite for practices interested in updated, comprehensive automation that also has patient experience-enhancing tools.

Our experienced Clinical Trials Team manages communications, education, software customization, and data collection.

Complete the form for more information on our MedicsCloud Suite for all of your EHR and PM needs, including clinical trials.