Solution used

  • Communications Portal

ABOUT THE CUSTOMER/CUSTOMER PROFILE

As one of the country’s most experienced and leading CROs (Contract Research Organization) for over 30 years, McDougall delivers valuable insight to biotech and pharmaceutical clients across all phases of their clinical trials. With timely, accurate data and analytics, McDougall helps clients expedite their time to market while decreasing development costs. Known for delivering exacting insights, McDougall works closely with companies to understand their business requirements, align with their regulatory strategy, and mitigate risks to deliver a vital statistical strategy for their product development.

Every successful clinical trial relies on expertly managed data operations. McDougall’s intelligent system ensures consistency and regulatory compliance while providing expertly managed data collection and validation. The company’s innovative technology ensures efficient statistical designs that expedite workflow and mitigate risks – resulting in a smooth, efficient and trusted operation from start to finish.

CHALLENGES

McDougall is known as a contact research organization (CRO) with emphasis on data and statistical services for clinical trials. Within these trials, McDougall defines the study and the instrument, executes the trial, cleans the data, analyzes it, and finally reports everything to the FDA. A portion of each clinical trial is conducted blindly where one algorithm randomly assigns a placebo or test drug to a patient/test subject.

McDougall also works with supply management. For example, a specific hospital may go through six drug kits and need to order more. McDougall will prevent these inefficiencies by programming a unique algorithm into the system to measure and track kits through shipping, delivery and integration.

In 2011, McDougall conducted an online search of interactive voice response (IVR) technologies, selecting several firms to receive a formal RFP. Enghouse Interactive’s Communications Portal (CP) met a number of McDougall’s high-level requirements at a reasonable price.

First and foremost, McDougall sought a system that had to be validated and could be implemented in a regulated environment. They also needed a system with continuous availability for clients via fail-over, high availability or another suitable technology. McDougall is a growing company, so it sought technology that allows for multiple IVR applications as well as additional telephony features that could be used by the McDougall offices.

In addition, the plan called for professional services. McDougall needed a vendor with comprehensive developer and system manager training that would guide users through the implementation process as well as ongoing training.

Other requirements included:

  1. The system be compatible with McDougall’s virtualized IT infrastructure.
  2. Application development not require unique/rare developer skills, but use a “modern” or common language or graphical user interface.
  3. The system integrates with McDougall’s MS SQL Server database system and web applications (IWRS and EDC).
  4. The system support four to 10 simultaneous calls from clients via one or two incoming telephone lines.
  5. The system supports outgoing faxes and emails.

SOLUTION

Enghouse Interactive Communications Portal (CP) is an open, standards-based platform with integrated application development and management components that significantly reduce the time, cost and complexity of deploying voice and IP communications solutions. CP combines the industry’s most complete support for IP communication, including telephony, video messaging, SMS and email with comprehensive support for traditional voice communication. By melding these capabilities, the multi-modal Communications Portal enables organizations to deploy all of their communication applications on a single, cost-effective platform.

The CP system empowers business communication through voice self-service solutions, including:

  • interactive voice response (IVR),
  • interactive video and video response (IVVR),
  • outbound dialing and
  • speech-enabled self-service systems.

In addition, the system offers:

  • SMS, email standards-based voicemail;
  • contact center solutions, including outbound dialing;
  • intelligent routing applications and screen pop applications;
  • unified communications solutions, including standards-based voicemail systems and applications that combine traditional voice, IP telephony, video messaging, SMS, email and fax communications; and
  • visual self-service solutions via web browser, smartphone, mobile or other connected devices.

Prior to CP, McDougall was using a Nortel system reliant on a PBX that was no longer supported, a situation that raised concern about service continuity. The new CP system, with a cold stand-by, has improved McDougall’s business continuity and the SLAs they can offer their clients.

At the time of the RFP, McDougall was migrating office phones to VOIP via SIP and the new IVR had to be compatible. The company required a vendor with solid support, including training, along with an extensive quality software development and maintenance process and schedule.

Randomization and drug supply management at McDougall is automated via IVRS/IWRS and provides client value by delivering just-in-time enrollment-driven supplies to study sites, lowering costs and optimizing supply inventory. Enghouse Interactive’s IVRS/IWRS has a global reach and is eminently flexible. It has allowed McDougall to customize applications to meet such unique client needs as:

  • Facilitating adaptive designs including dose escalation
  • Implementing complex randomization allocation and trial supplies management schemes
  • Capturing Patient Reported Outcomes (ePRO)
  • Conducting surveys
  • Recording patient trial status such as reasons for failing screening
  • Executing emergency code break procedures
  • Sending automatic notifications and confirmations triggered by specific actions or events
  • Email confirmation of subject randomization

BENEFITS/RESULTS

Since the system’s implementation in 2013, McDougall has seen a number of positive results. For example, when sponsors of studies needed to set up new centers, McDougall would only need to set them up with a phone number. In addition, the company has developed key business metrics in time and on budget. Since installing the system, McDougall has more efficiently addressed complex randomization schemes and drug inventory management, as well as system availability.

For randomization research participants, McDougall clients have called the IVR application to randomize:

  • cardiac patients on the operating table waiting to receive a stent,
  • pediatric dental patients in the dentist’s chair waiting for treatment,
  • patients with ulcer, and
  • retrieved information stored in the Electronic Data Capture (EDC) via web application API/Web services.

For drug supply management, the IVR has alerted clients when supplies were:

  • due to expire and had to be replaced,
  • below a supply threshold and had to be replenished, and
  • coming from multiple depots and requiring tracking from those sources.

The new system also ensures scalability. This includes auditing trials, securing access, the ability to adhere to requirements, testing and confidence in the system’s development lifecycle. Moving forward, McDougall is in the early stages of implementing live chat and custom integration with Tesitura.