Client Case Studies

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Flexible Implementation with TEMPO

Stre-e-e-etching Clinical Research Dollars Enables On-X to Continue Investing in Product Innovation

On-X Life Technologies, based in Austin, knew it had a great product with its On-X® Prosthetic Heart Valve

Small Company, High Stakes
“We’d spent over a decade on this technology, and the valve was already at the top of its class in valve performance,” said John Ely, Executive Vice President for Regulatory Affairs. “Patients were seeing important quality of life benefits that merited additional study, and we were ready for the next phase—post-approval research—to explore these benefits.”

With FDA approval, the On-X valve would be the only mechanical heart valve available in the U.S. for low-dose anticoagulation therapy. “We had to find the right partners to work with us,” John said. “We needed a web-based product that met all of our needs for data capture and study management.”

On-X gained FDA approval to begin the trial, and medical researchers in dozens of prestigious medical centers across the U.S. were in place to begin.

The randomized control clinical trial of the On-X Prosthetic Heart Valve involves up to 1,200 patients across 40 different medical centers nationwide. Compared to other medical device trials, theirs is a large study. Stakes were high in finding an experienced company with the software to manage, track and report on all facets of the study. “At that time, the issue of upfront costs was also especially important,” he said. “As a small medical device company, we needed a partner who understood our business cycle and company stage.”

Some software providers proposed charging five figures per month to provide what On-X needed. With healthcare IT costs coming down in many areas—for storage in particular—these high costs did not make sense to the decision-makers at On-X, so John kept looking.

Flexibility Creates Significant Cost Savings
After researching five vendors, On-X chose Clinipace’s TEMPO clinical research software platform.

“Not only was the cost reasonable, they were willing to offer flexibility in terms,” John said. “Trials are expensive, and they understood our needs.” Perhaps most compelling for On-X, Clinipace also offers flexible implementation options.

They identified even more cost savings after comparing the expense of outsourcing the management of this part of the trial to the cost of On-X combining their own internal resources with the use of Clinipace’s technology. They determined that with TEMPO software, they could provide project management themselves with a team of three internal people. Total cost savings: 50 to 60 percent – over $2 million—compared to other vendor’s options.

Investigators Find Software Robust and Easy to Use
As the On-X team put the software to work, their choice of TEMPO was confirmed.

“John knows the regulatory environment,” said Clinipace’s Chris Porter, Chief Operations Officer. “He spent over seven years as an FDA employee, so he knew exactly what functionality he needed in a software platform to track and report progress during the On-X heart valve study.”

Since beginning the trial, site investigators have offered their own evaluations of the software. They say data entry simple, the web-based platform convenient, and the paperless system has huge advantages. Investigators also told On-X officials that the “serious adverse event” notification is particularly helpful.

“The software deployed quickly, and the investigator sites love it,” John said. “Several investigators have actually volunteered to tell us how well TEMPO works in managing the study.”

In addition, On-X needed to coordinate shipping and management of the lab draws and specimens with their central laboratory in Canada. “I’ve been in this industry a long time,” John said, “and this is the first tool I’ve seen with the flexibility we needed to manage our research processes.” TEMPO enables investigator sites to alert the lab of new specimen shipment and for lab personnel to confirm receipt and notify the site if and when the specimen was accepted for processing.

“The granular permissioning system enabled us to collaborate with the laboratory personnel,” he said. “Now everyone is on the same page regarding the status of specimen shipments and processing. The workflow was complex, but TEMPO made it easy.”

Process Improvement Leads to Product Innovation
By choosing the right partner, On-X and their investigator teams are now concentrating on patient outcomes and evaluating clinical benefits, not on learning software or tracking the complexities of the workflow process.

Due to On-X’s dedication to their product, patients who need prosthetic heart valves are many steps closer to eliminating a life-long need for higher doses of anticoagulation medication.

On-X has also turned to Clinipace products and services to support other important projects.

“While our relationship started initially as a high-priority Phase IV study, we’re leveraging the same infrastructure to conduct a nonrandomized observational safety study,” John said.

On-X expects that the cost savings they realized by relying on the Clinipace TEMPO software can be invested into further product development.

Gain Trial Visibility and Cost Savings

Inspire Pharmaceuticals Gains Trial Visibility and Cost Savings with Clinipace Worldwide’s Technology-Amplified Approach to Clinical Trials

Inspire Pharmaceuticals, a North Carolina-based biopharmaceutical company, focused on developing and commercializing prescription products for ophthalmic and pulmonary diseases previously worked directly with investigative sites to manage clinical trials for its initial drug portfolio. Generally reluctant to outsource the management of studies, the company felt it was good at developing relationships with investigators and worked hard to build and maintain those relationships.

However, as their portfolio grew, the company began to realize that time spent managing trials was time taken from development and other core competencies. One of the key executives on the clinical operations team had significant experience working with large CROs, and he knew the particular dynamics of those relationships that worked, and those that didn’t. For example, in the past, even when asking for very basic study metrics, it would sometimes take weeks to get an update. Accordingly, study visibility and open access to real-time data were high on the company’s list of priorities for strategically engaging the right CRO partner.

The company had previously deployed another of Clinipace’s technology-based research software solutions and thus established a good working relationship with the executive team. As a result, they selected Clinipace Worldwide to manage and deploy two Phase II randomized placebo-controlled studies for an ophthalmic prescription medicine.

Process in Motion
For the studies, Clinipace provided technology-driven clinical trial services including data management (EDC), clinical monitoring, site management, regulatory document management, and biostatistical consulting. The project team utilized Clinipace’s TEMPOTM for Clinical Trials software to manage site initiation, patient enrollment and randomization, clinical data capture, and much more. TEMPO’s dashboard shows real-time data such as patient enrollment, reports, and other notifications – greatly increasing visibility into the ongoing trials.

“We share a common goal with Clinipace of changing the way we approach the clinical development process – shifting away from some of the more traditional CRO processes and moving towards an integrated technology-driven model.”

- Senior Director, Clinical Ops [Inspire]

Conducting the studies electronically provided real-time visibility into site data, compared to a more traditional and time-consuming process of submitting multiple queries and addressing discrepancies towards the end of a study. Clinipace credits a strong relationship with its study sites in generating transparent data throughout the entire research process –valid data was input electronically, monitors did their jobs expertly, and necessary changes were made as required so site visits were more efficient and productive. As a result, teams were able to “clean” data as they went along and ultimately close-out the second longer-term Phase II study 2-weeks earlier than originally planned.

The successful completion of the two Phase II studies set the foundation for a longer-term relationship between Clinipace Worldwide and the pharmaceutical company. Clinipace closed out a data management project for a Phase IV study in early 2010 and a Phase II pediatric study recently went live and enrolled its first patients. Clinipace will support the Phase II trial with data management and biostatistical consulting.

“Having the opportunity to strategize and collaborate with a trusted clinical research partner in an ongoing relationship allows you to fine-tune processes and apply best practices for future engagements. We’re always looking at, ‘What can we do better for the next phase or project?’, ‘How are we going to handle this type of situation in a bigger study?’ By building relationships with project managers, we have a head-start for the next phase or project knowing what they’re looking for, how they operate, and how we can help the workflow run more efficiently within their parameters.” 

- Chris Porter, COO [Clinipace Worldwide]

Measuring Success
Since building a strategic partnership with Clinipace Worldwide, the pharmaceutical company has reaped the benefits:

Greater visibility and two-way communication
Clinipace Worldwide and the company built a successful business relationship based on transparent information exchange, mutual trust, honesty, and open communication. With fewer layers of management to navigate, the company gained greater visibility into all aspects of their trials and better two-way communication with the Clinipace team. The company credits Clinipace’s responsiveness for helping to avoid problems and mitigate risks.

“We especially like having the ability to communicate directly with senior members of the Clinipace team. It is important to us that we are important to them. As much as we value open communication, trial visibility is equally important as many program decisions must be made internally.”

- Senior Director, Clinical Ops [Sponsor]

Strong working relationships with research sites
As a clinical operations-oriented CRO, Clinipace Worldwide emphasizes the need for building strong working relationships between experienced site monitors and the company. Clinipace’s clinical team serves as technology advocates, acting as an extension of the company’s staff, actively participating in team meetings and mission-critical decisions.

“As a relatively small biopharma company with several parallel projects, we see real competitive advantage in building a strategic partnership with a responsive CRO who can maximize the operations of our clinical programs. Every efficiency gain goes right to our bottom line.”

- Senior Director, Clinical Ops [Sponsor]

Rapid course corrections
Operating under a fixed-price contract allowed Clinipace to make rapid course corrections based on real-time information. Clinipace has the flexibility and agility to make changes to deliverables and deadlines by mutual agreement among team members, as opposed to extended negotiations, scope of work changes, and contract addendums.

“We’re hearing from the market time and time again that companies are tired of having over-scaled and over-priced resources pitched to them. That’s the driving force behind our dedication to providing innovative companies a scalable solution with the right kind and quantity of resources to match any size clinical study and operational approach.”

- Chris Porter, COO [Clinipace Worldwide]

Optimally designed trials
Optimally designed trials that are conducted correctly the first time are crucial for success. Clinipace has the breadth of expertise to design trials for the company that helped to achieve stated clinical, regulatory, and commercial objectives in a focused and efficient manner – all within their stringent timelines.

Maximized efficiencies and reduced costs
Rather than depend on volume for efficiency gains, Clinipace Worldwide seeks innovative new technologies and processes that often can’t be introduced into larger CROs with entrenched procedures. For example, Clinipace’s TEMPO technology platform brought together multiple sources of data that would have otherwise needed manual intervention.

Emphasize core strengths
Capitalizing on Clinipace’s expertise and capabilities as a CRO has allowed the company to focus on its own core strengths rather than organize, create, and administer a complete clinical trial themselves.

* Inspire was acquired by Merck in 2010

Save Time and Eliminate Hassle in Geographically Dispersed Trials

Neuroscience and Spine Institute at the Carolinas Medical Center Saves Time and Eliminates “Hassles” in Conducting Geographically-Dispersed Stroke Study

Big Project, Small Budget
Andrew Asimos, MD, Director of Emergency Stroke Care at the Carolinas Medical Center in Charlotte, NC, and site investigator for the North Carolina Collaborative Stroke Registry (NCCSR) wanted to validate guidelines for risk-stratifying patients who experience a Transient Ischemic Attack (TIA), also called a mini-stroke. Developed in a landmark 2000 Kaiser Permanente study, the guidelines purport to predict whether these patients would go on to have a full-fledged stroke in the short term.

Dr. Asimos recognized that the registry he was already participating in could serve as the backbone for additional research. However, with a small research budget and staff, he wasn’t sure how he could undertake such a large scale project that would require him to work with more than a dozen hospital sites and extremely busy emergency room personnel.

Based on his previous experience, Dr. Asimos knew it would take months to identify the appropriate hospital sites and another 24 months to collect enough clinical data to validate the guidelines and risk profile–time he simply did not have if he wanted to meet his research and publishing objectives.

Relationships Built with Trust
Because the NCCSR was already a customer of Clinipace, Dr. Asimos approached the company about using its TEMPO platform to conduct his research. According to Dr. Asimos, “Clinipace was extremely accommodating from a budget, regulatory, and deadline standpoint. I needed to recruit 1,500 to 2,000 patients, so identifying hospitals with large numbers of eligible patients was imperative. With Clinipace’s research software platform in use within the NCCSR, finding the right hospitals to participate in the study took minutes, not months. The reporting engine within TEMPO made patient recruitment straightforward and easy to manage.”

“The NC stroke registry was the perfect venue for conducting this validation study,” said Dr. Asimos, “since the two efforts were related.”

Dr. Asimos ultimately secured 16 North Carolina hospitals to collaborate with him. TEMPO’s web-based workflow platform was the perfect solution for managing a geographically-dispersed research project that relied on hospital sites to collect information within the emergency department. The software was also very easy for busy ER physicians and nurses to use. “Clinipace allowed me to easily manage the project without creating a burden for our hospital sites and busy data collection team [given this wasn’t their primary job],” said Dr. Asimos.

As important as data collection was to the success of this project, managing various workflows and ensuring timely follow-up was even more critical.

“Each hospital needed to follow up with patients twice during the study period. Utilizing TEMPO’s built-in workflow engine and reporting tools, we were able to automatically assign follow-up tasks and provide reminders to each stroke program coordinator. Since information was able to reach the research team in real-time, team members could quickly run reports [within their appropriate permissions] to keep up-to-speed on enrollment and follow-up milestones. Having instant access to data made managing the project very easy,” explained Dr. Asimos.

Faster is Better
Due to the flexible workflow platform, Dr. Asimos was able to identify potential hospitals within hours, not months, and the research/data collection phase of the project was completed 79% faster due to collaboration between NCCSR, Dr. Asimos, and Clinipace.

Dr. Asimos explains, “I was able to significantly reduce the time it would have taken to identify sites and eligible patients by mining the registry data. The collaborative nature of the relationship between NCCSR and Clinipace, as well as the software platform, flexible workflow processes, and real-time reporting enabled the project team to complete the research phase in as little as 7.5 months. Without the collaboration a similar project would have taken me 3 years.”

Dr. Asimos further explains, “I would have never been able to do a project this ambitious within my budget without Clinipace. I would have had to do all the data collection and analysis on paper—which would have totally undermined my ability to do the project. Clinipace also deeply understands the regulatory environment of academic research which helped me tremendously as I prepared and conducted this research.”

Currently, the research phase of the project is complete and the data is being analyzed at the University of North Carolina, Department of Epidemiology within the School of Public Health. Dr. Asimos expects to submit the finding for publication later this summer.

Oncology Expertise and Robust Electronic Data Management

Client Snapshot: Prometheus Laboratories

“Patient enrollment is one of the biggest challenges we face when starting an oncology trial; thus, it was critically important for us to team with a CRO we felt could provide oncology expertise along with a robust electronic data management platform.”

- Todd Butler, Director Clinical Operations, Prometheus Laboratories Inc.

How can technology optimize patient enrollment and monitoring in early phase oncology trials? Learn how Clinipace Worldwide is helping Prometheus Laboratories, a specialty pharmaceutical and diagnostic company, enroll patients and integrate technology into two metastatic melanoma studies.

Learn more about the role of technology in trial start-up and patient monitoring, and how Prometheus Laboratories can monitor critical study areas in real-time and adjust patient enrollment strategies with improved data quality.

Increased Trial Agility, Efficiency and Consistency

Clinipace Worldwide Delivers Transparency in the Successful Performance of a Phase III Dialysis “Rescue” Trial

The “David” of CROs among a sea of “Goliaths” restored trust to the trial offering agility, efficiency and consistency that traditional models often lack

A west coast biopharmaceutical company was in the process of a Phase III dialysis trial involving over 100 North American centers and approximately 1500 patients. Originally contracting a larger CRO for the study, this complex trial required concentrated monitoring and tight project management. As the trial progressed, the company realized the large CRO lacked transparent trial management and the resources required to complete the trial in time to meet New Drug Application (NDA) goals and investment-related deadlines.

Looking for a partner that would provide more trial performance visibility, the company employed Clinipace Worldwide in October 2009 to “rescue” and augment the monitoring of the trial, effectively manage and achieve milestones, meet project timelines, and optimize resources and communication pathways.

Process in Motion

With a resource model based on the needs of each customer, the biopharmaceutical company chose Clinipace Worldwide to save money and time.  A more efficient and affordable study with “lean” clinical research processes would minimize data integration, reduce project startup costs, and empower project stakeholders to make informed data driven decisions.

Needing to get a handle on the backlog built up from the previous CRO, Clinipace Worldwide leveraged its CRA network to deploy 37 monitors in less  than two weeks. Clinipace Worldwide conducted a two-day training session for  all CRAs in collaboration with the sponsor, and was able to deploy monitoring  teams virtually immediately, typically unheard of, and get the process up and  moving again very quickly.

Clinipace Worldwide, unlike other CROs, enables its Clinical Research Associates (”monitors”) to serve as the site manager.  This ensured strong monitor site relationships and expedited replies to monitoring requests.

The synergy of this relationship was beneficial to all parties and made execution of requests  smooth and timely.  The trial team escalated findings of inadequately monitored  tasks across the team in weekly Clinipace Worldwide conference calls. This ensured the entire monitoring team was on the same page to apply solutions  and increase data quality.  These findings were also crucial from a communication perspective as the project management team was able to relay this information to the client and allow for “real time” assessment and decision making to address the findings in a number of ways (i.e., client Good Clinical Practice (GCP) audits, client interaction, etc.) and improve overall data quality.

In addition, Clinipace Worldwide remediated accrued documentation and files from the sites previously managed by the other CRO, and implemented integrated monitoring and study management practices to ensure data quality.  Clinipace provided 100 percent transparency in all operational transactions with the trial and remained consistent throughout the entire relationship. Any bumps along the way were reported, assessed and fixed. There was never a doubt as to what work was being done, how, and the results.

The clinical operations services enabled the biopharmaceutical company’s stakeholders to view the study’s progress anyplace and anytime, and make informed real time decisions regarding their research leveraging,

  1. Data validation and cleansing
  2. Quality assurance
  3. Data reconciliation

The company also needed to ensure regulatory compliance within the various documents and data coming from and going to each site. Clinipace Worldwide managed site logistics, documentation, reporting, and site file notebooks, regulatory file review, site status reporting, and site close out tasks.

Measuring Success

From an investment standpoint, the biopharmaceutical company measured success on timeline. If the company didn’t complete the trial with data cleaned and locked, the investors would not be in a position to make the commitment needed to advance the drug.  Throughout the time that Clinipace Worldwide was involved with the study, a Governance Committee made up of executives from all service providers involved in the trial met to discuss strategy and solutions.

With a commitment to open and transparent communication, a checks and balances of processes in place provided:

  • GCP adherence
  • Project visibility and lifecycle management
  • Comprehensive project and communication plan
  • Collaboration with sponsor to create monitoring, and site management plans
Improved Care and Outcomes Associated with Crohn’s Disease

Clinipace Extends Research Partnership with the ImproveCareNow Collaborative to Accelerate Care and Treatment of Pediatric IBD

The ImproveCareNow Collaborative, formerly the PIBDNet Trailblazer Improvement Collaborative, allows selected practice sites to work together to improve the care and outcomes associated with Crohn’s disease and ulcerative colitis. ImproveCareNow’s mission is to enable pediatric gastroenterologists in North America to work together to find the best treatments for these diseases. The most common serious chronic pediatric gastrointestinal disorders, these conditions affect 100,000 children and adolescents in the USA.

Establishing Original PIBDNet Trailblazer Registry
In 2005, Clinipace helped establish and manage the original PIBDNet Trailblazer registry, operated by the University of North Carolina at Chapel Hill and the University of Vermont with support and assistance from the American Board of Pediatrics. The original registry was designed to evaluate over time children and adolescents with IBD in an effort to better understand this debilitating disease, methods of prevention and treatment, and ultimately improve care.

The network’s initial patient registry was created using a homegrown solution. However, this system presented several challenges with regards to cost and complexity. With over 200 sites from which to collect data, the collaborative required a solution with an easy-to-use web-based interface to enable data entry from any location that would then be available in real-time to investigators.

According to Dr. Richard Colletti, Principal Investigator of the ImproveCareNow Registry and Vice Chair of the Department of Pediatrics at the University of Vermont and Associate Chief of Vermont Children’s Hospital, “Our in-house system was costly to maintain, not to mention expensive and time consuming to change. In fact, the data management costs were so high that we would have had to end the project if we couldn’t find an alternative.”

Why Clinipace? Affordable, flexible, data compliant, high-level of customer support, user-friendly
After exploring a number of options, Dr. Colletti’s team selected the Clinipace technology-driven data management solution. “We felt that Clinipace services would be more affordable and that it would provide the ability to make changes in a flexible and timely manner.”

In addition, Colletti appreciated the fact that the Clinipace software is compliant with FDA 21 CFR Part 11 and that Clinipace consultants are very careful about data privacy. Dr. Colletti added, “The data is stored like Fort Knox. It’s reassuring.”

According to Dr. Colletti, during the study start-up process, “The Clinipace consultants were friendly to work with. When challenges arose, we got the support we needed and issues were resolved quickly. The Clinipace electronic data capture (EDC) platform is user-friendly, reliable and meets all of our needs at a reasonable cost – which has enabled the project to continue its successful work. Once the system was up and running, the data entry people found it very easy to use. We rolled the platform out to 200 sites and investigators used it with very little difficulty.”

Supporting ImproveCareNow Collaborative
Pleased with the quality of data received from the first registry, the rebranded ImproveCareNow organization joined forces with Clinipace to provide the technology backbone for the ImproveCareNow collaborative.

With 16 sites across the US from Maine to California, the collaborative has already enrolled over 2,000 patients, with plans to expand to 75 practice sites within 5 years. To date, the collaborative has succeeded in improving the detection of nutrition and growth failure; standardizing disease diagnosis and initial evaluation; and building assessment of disease severity and extent into every patient visit.

Project coordinators have seen a substantial increase in the reliability of care delivery as well as a decrease in variation in care processes and outcomes among sites. Recent data, based on monthly reports from Clinipace, indicates that the collaborative is beginning to see an improvement in the remission rate, with more children having inactive disease.

“Clinipace’s technology and data management services allow us to provide our patients and families at the participating practice sites data-driven, evidence-based and reliable care tailored to their individual disease status and needs,” said Colletti. “We are now working with Clinipace to develop systems that will allow patients to provide their providers with updates on their disease activity and status between clinic visits.”

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