Clinipace

Ranked 485, (and ranked 32nd in our industry) Clinipace is listed among the most successful private companies that have experienced substantial revenue growth over a three year period (2006-2009).

As we’ve been preaching to all that will listen, this recognition confirms that Clinipace Worldwide is changing the face of global life science clinical research and development through its technology-amplified approach to conducting and managing clinical trials. The company is guided by the philosophy that technology is not an add-on to clinical trial processes; it is the backbone on which expert services are built.

A real demand exists for transparent and fully-integrated clinical research solutions among mid-tier biopharmaceutical and medical device firms, as proven by Clinipace Worldwide’s triple-digit growth over the past 12 months. Revenue exploded 614% over the past three years and the company expects 2010 revenues to more than double over 2009.

Although the current shift occurring in clinical research is fueled by technology, the people behind the services are the lifeblood of the transformation. Clinipace’s impressive growth could not have been possible without the dedication of its stellar employees and their strong commitment to superior customer service and support. A devoted customer base challenges Clinipace to not only meet, but exceed expectations.

Thank you to our great employees and clients

One of today’s most important emerging regions for clinical trials is Latin America, which is being increasingly considered for trials because it offers significant potential.

Regulatory enforcement bodies, quality investigators, ethics committees ensuring patient safety, proactive Good Clinical Practice (GCP) policy development, and huge research naïve populations have been cited as contributing to Latin America’s explosive growth.1 Yet, as in many regions, important challenges remain, including language and cultural barriers.

Check out the full article we wrote for Applied Clinical Trials on conducting trials in Latin America.

[This post is the third in a three-part series about the transformations occurring throughout the clinical research industry and Clinipace Worldwide's effort to bring more efficiency and transparency to the process.]

As a result of the digital Clinical Research Organization transformation, clinical trials have better quality control, run with enhanced efficiency, greater transparency, and at reduced cost.

Better Quality Control

The ultimate goal of conducting a clinical trial is to obtain clean, quality data upon which the US FDA, healthcare providers, and the healthcare consumer can rely. The ability to attain this data depends upon expert and experienced people, good systems, and good processes. The dCRO applies the right people to the proven processes and systems to ensure quality. The integrated nature of these trial processes and robust technology-amplified data validation enhance quality control and serve to minimize project risk.

Enhanced Efficiency

In addition to enhancing quality control, technology adoption by all project constituents helps to target the use of resources that lead to greater efficiency in the conduct of clinical trials:

• Study Start-up: Information from pre-study visits are communicated more quickly, site initiation activities and regulatory documents are universally shared and better managed; leading to reduced cycle times and faster site activations.

• Patient Accrual: With current, at-the-fingertips information on recruitment rates, resources can be directed more appropriately.

• Clinical Monitoring: Just-in-time monitoring, driven by site-based data collection and activities, enhances productivity while reducing unnecessary visits.

• Site Management: Automated tracking of site activities enhance the efficiency so when contractual milestones are met, sites are paid promptly, making for satisfied investigators.

• Drug/Device Supply: Combining real-time enrollment visibility with drug inventories and dispensation enables efficient timing and deployment of study drug kits and thereby reduces costs.

• Study Close-out: Consistent remote and just-in-time monitoring enables timely resolution of data discrepancies (even preventing problems), ensuring higher-quality data and faster database lock; allowing analysis and site close-out visits to occur much earlier than with traditional processes.

Greater Transparency

The transparency of performance metrics that underlie dCRO methods serves to instill sponsor confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are/were operationalized in the trial. The integration of clinical and meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial.  The use of technology thus enhances quality control and project efficiency; but also makes the evidence of these artifacts easily manifest through the use of performance metrics, such as:

Site Activation

• Cycle time to site qualification
• Cycle time to first site activated
• Cycle time to site activated
• Regulatory pack approval rate
• Percent planned sites activated

Site Performance

• Cycle time from activation to FPFV
• Site productivity (% meeting goals)
• Screen failure rate
• Patient accrual
• Patient drop out rate

Data Quality

• Cycle time to CRF data entry
• Data discrepancies
• Query response time
• Source data verification

Close Out

• Cycle time for query resolution
• Cycle time from LPLV to data lock
• Cycle time to site close out
• Issue identification & resolution

Reduced Cost

The dCRO approach to resourcing clinical trials reduces costs by turning the traditional CRO approach to clinical trial resourcing on its head. Traditional CROs sell people by the hour and add technology to the people at additional cost. Traditional CROs also compartmentalize clinical trial functions, a practice that results in redundancy and wastes time (and, therefore, money) because of communications challenges.

The adoption of dCRO methods and the technology-amplified approach to clinical trials have brought about a shift to a new clinical research paradigm in which integration, collaboration, and transparency foster an unprecedented level of information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial. The paradigm shift is transforming the process, quality, cost, and outcomes of clinical research for the better.

Based on our tremendous growth in new clients and projects over the past few years Clinipace Worldwide, a global full-service CRO, has been recognized as a Top 100 North Carolina Small Business  for 2010 by Business Leader magazine, a leading business publication focused on the companies, leaders and trends in the North Carolina business community.

Clinipace Worldwide ranked #7 in North Carolina, and #2 in the Research Triangle Park, up from #52 in 2009.

Business Leader’s list of Top 100 North Carolina Small Businesses is comprised of firms with 100 employees or less that do the majority of their business in North Carolina. Each company’s one-year and five-year revenue growth, business achievements and community involvement were evaluated during the selection process.

[This post is the second in a three-part series about the transformations that are occurring throughout the clinical research industry and Clinipace Worldwide's effort to bring more efficiency and transparency to the process.]

The new clinical research paradigm is characterized by a unified technology that enables integration, collaboration, and transparency across all stakeholders: integration and collaboration among functions and roles across the spectrum of clinical trials components (e.g., Site Selection/Management, Patient Recruitment, Project Management, Monitoring, Data Management, Biostatistics) and project- and stakeholder-wide transparency of both clinical research processes and clinical trial metadata.

In the new clinical research 3.0 paradigm, integration and transparency foster an unprecedented level of information sharing, enable efficient information analysis for better decision-making, and provide the environment for conduct of a frictionless clinical trial.

While similar in many ways to a traditional Contract Research Organization, the dCRO is built around a vision of clinical research 3.0, which improves upon the traditional Contract Research Organization model by using technology-amplified processes to improve trial performance, visibility, and coordination among all stakeholders. Clinical research software integrates the spectrum of clinical trials functions in one platform accessible to all stakeholders; eliminating silos, which are often times, conceptualized and operate independently, each with its unique budget, systems, and software.

In contrast to the traditional CRO, which views technology as an add-on to a personnel-based system, the dCRO begins with technology as a platform and adds to it the minimum number of people to do an effective job. With judiciously employed technology, fewer people and resources are needed to do a job. In the dCRO, technology carries some of the work burden that would typically be carried by people, so the people component is smaller and less expensive.

Technology Is the Backbone of the Transformation, but People Are Its Heart

Although the current transformation occurring in clinical research (led by Clinipace Worldwide) is fueled by technology, technology is not its heart. Rather, people who share a vision of technology as a tool that can bring both unsurpassed efficiency to the process of running a clinical trial and unsurpassed quality to clinical trial outcomes are the heart of this research transformation.   A shared passion for using technology for the success of the project underpins the culture of a dCRO.

To those people working in the digital Clinical Research Organization, technology is not an add-on to clinical trial processes; it is the backbone.  The dCRO is guided by the philosophy that using technology to drive the clinical research process optimizes outcomes. The soundness of this tenet is intuitively obvious: in the process- and regulation-driven setting of a clinical trial, the use of technology should make the processes more organized, efficient, and transparent.

While clinical research cannot be completely automated, technology can bring visibility and control to a level not previously possible. In the dCRO model, technology facilitates the optimization of tailored resources so that just the right number of individuals—that is, the minimally effective number of individuals—becomes engaged in clinical trial management. In contrast, the traditional approach to clinical trials centers on providing (selling) people by the hour and each stakeholder adds his or her specialized technology. This approach increases costs, reduces collaboration, and makes processes more complicated.

The dCRO approach of using technology to optimize tailored clinical trial resources is changing the face of clinical research. Project stakeholders’ adoption of technology is transforming the way teams work individually and collectively toward common goals. As a result of these changes, clinical trials have better quality control and are run with greater efficiency and at reduced cost.

In part three, we’ll discuss the how the entire ecosystem will benefit from this transformation.

This morning we announced that Vaccinogen, a biotechnology company with more than three decades experience researching how to combat cancer using the body’s own immune system, has selected the company to manage a pivotal phase 3b confirmatory trial for OncoVAX® in the treatment of Stage II Colon Cancer.

With colon cancer being the third most common form of cancer and the second leading cause of cancer-related death, OncoVAX® has the potential to fulfill an unmet medical need. In the phase 3a study, OncoVAX® significantly reduced tumor recurrence following treatment in the earlier stage of colon cancer where the current standard of care is surgery plus observation, enrollment in a clinical trial, or consideration for chemotherapy in some.

The phase 3b study is a randomized, controlled trial in Stage II colon carcinoma in which OncoVAX®-treated patients will be compared with control patients having surgical resection alone (the standard of care). A total of 550 patients will be enrolled in at least 47 centers in the US, South America, and Europe.

Vaccinogen begins its study with Clinipace on the heels of recent news announcing the first autologous immunotherapy approved by the FDA to treat cancer – Dendreon’s Provenge, a breakthrough cancer vaccine that promises to extend the lives of men with advanced prostate cancer.

Read the full announcement