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

Great news for our employees, partners, and clients.  Today we were named one of 25 North Carolina Companies to Watch by CED, a private, nonprofit organization that promotes entrepreneurial efforts in North Carolina. The inaugural class of North Carolina Companies to Watch represent growth-stage entrepreneurial companies that demonstrate high performance in the marketplace, exhibit innovative products or display other unique qualities that make them “worth watching.”

The North Carolina Companies to Watch were selected from an initial pool of 190 nominees from across North Carolina. They are privately held companies of between 6-99 employees and $1 million to $50 million in annual revenue or funds raised from grants, investors or partnerships. The winners represent the geographic regions of the state as well as different sectors of the economy.

Full press release

Transforming the Way Project Teams Function

In the dCRO, clinical research and operations software (that is, “eClinical”) integrates in one platform the spectrum of clinical trials functions including Project Management, Data Management, Monitoring, and Data Analysis and Reporting. With the aid of collaborative technology, every stakeholder involved in a project works around the same hub, uses the same tools, and has instantaneous access to the same information. Walls that separate functions in the traditional CRO are thus broken down in the dCRO, where information flows quickly and freely among project stakeholders.

Clinical trials processes, data, and metadata are transparent to all stakeholders. Technology-enabled processes obviate the need for hours-long meetings devoted solely to ensuring that all project stakeholders are abreast of the most current study status and issues. Likewise, rigid definition of functional areas within the project team is not required. The project team becomes more efficient because all stakeholders are working with the same information.

The integration that characterizes dCRO contrasts with the compartmentalization of the traditional CRO, where clinical trial functions are separated into silos. In the traditional CRO approach, each clinical trial function is typically managed by a different group, and communication among groups is difficult to foster. According to one sponsor of a technology-amplified study, “It used to be that when I asked how many patients had been enrolled in one of our trials, I got five different answers depending on the department to which I directed the question. What’s more, it took anywhere from 30 minutes to 24 hours to get those five answers. Now, the answers to these questions are immediately available at my fingertips.”

Transforming the Roles of Individuals Involved in Clinical Research

In the digital Clinical Research Organization, instant and easy access by all project stakeholders to up-to-date trial metadata has transformed the roles of individuals involved in clinical research by enabling a shift from a focus on logistics and processes to a focus on strategy and issues. Because every stakeholder involved in a project works around the same hub, uses the same tools, and has instantaneous access to the same information, individuals whose efforts are devoted primarily to monitoring, status tracking, and status reporting can focus their time on making strategic contributions through trouble-shooting, streamlining, and decision-making.

Project transparency that enables critical decision-making is the hallmark of technology-amplified processes. In the dCRO, clinical teams can devote time to appropriate resource management rather than tedious maintenance of status spreadsheets. Similarly, clinical monitors with immediate access to data can function as coaches to study sites rather than as clerks or auditors.

In the traditional clinical research model, site monitor visits can often be invasive and disruptive as investigators and research staff scrambles to provide information needed by the clinical research associate (CRA). Clinical aspects of the study may be de-prioritized temporarily with a negative impact on both study progress and the sponsor-site relationship.

Because the eClinical systems in the dCRO enable real-time trial enrollment visibility and confer the ability to identify and resolve data discrepancies remotely, CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event (Just-in-Time Monitoring).

This model deploys CRAs more efficiently than the traditional model, facilitates identification of issues or problems and enables earlier corrective actions, thereby reducing costs and enhancing study quality. Continuous remote monitoring of trial data and site performance via technology also helps to make visits more efficient and purposeful. Instead of having to spend days at a site reviewing vast amounts of information, a CRA can remotely identify issues that need to be addressed during the on-site visit. Continuous, real-time, remote access to site data thus allows visits to become strategic in nature such that the CRA and site personnel work together to solve specific problems and set goals.

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.