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

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.

Thought you’d enjoy this quick read. State bans on physician gifts impacting conference goodies. At DIA next week, we’re giving $10 iTunes cards, but will make sure not to hand them out to practicing physicians, just to be safe

From today’s FiercePharma newsletter…
You’ve heard that there’s no free lunch, but no free coffee? One of the trends noticed at last weekend’s American Society of Clinical Oncology meeting was careful policing of just who took free lattes. No Vermonters were allowed at the Pfizer coffee machine, thanks to that state’s strict rules on pharma gifts for physicians–and no Minnesotans, either.

And those doctors who did collect a cup of joe? They’ll see their names on the Pfizer website, a company spokesman promised Reuters. “Any gift, even a cup of coffee, is posted on our Pfizer website for disclosure purposes and to provide complete clarity.”

One international drugmaker even limited coffee handouts to doctors with international ID badges. A woman stood guard, in fear that the FDA’s handout police would come calling.

It’s a far cry from the ASCO exhibit floor of the past, where doctors could pick up all sorts of drugmaker tchotchkes. Apparently, pharma companies are really taking the new PhRMA gift guidelines seriously. In some views, too seriously. “This is getting to the point of absurdity,” a deputy CMO at the American Cancer Society remarked to Reuters.

[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.