Clinipace

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

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 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

Reserve your seat- February 24th, 2010 at @2pm EST - as we host the first event in our 2010 webcast calendar. The webcast, 5 key reasons to make the move to just-in-time clinical trial monitoring, will be presented by Carla Radke, R.N., CCRP, associate director of clinical monitoring at Clinipace Worldwide; and Laurin Mancour, CCRA, CCRP, RAC, clinical trial consultant.

Both experts in clinical trial operations will share their insights and experience in utilizing a new approach in site monitoring, that we call Just-in-Time Monitoring. This methodology has been successfully deployed on several projects, including two recently completed (locked) trials.

Join Carla and Laurin for this FREE 45 minute webcast - Register today.

Carla Radke offers this analogy, “Traditional site monitoring is like major exploratory surgery, where the patient is opened up from stem to stern to look for problems. It causes serious disruption while trying to find a faulty system or a disease process, with the possibility of missing more subtle clues to the patient’s health.”

Just-in-time monitoring of clinical trials can also be far less invasive and disruptive. By adopting this new monitoring approach and utilizing an integrated clinical operations and data management platform, CRAs can provide a new level of monitoring service that pinpoints problem areas and pays more attention to early warning signs.

A key aspect of realizing the benefits from just-in-time monitoring is to actually incorporate the data-driven model into clinical trials. Many study sponsors and sites are using technology to collect and store trial data, but haven’t taken the next step to integrate the data from disparate systems into meaningful information.

In these cases, technology-based data collection is not much more useful than collecting it manually, and in fact adds an extra step to the process. To avoid being burdensome, data collection tools must be incorporated into the overall study framework in a way that encourages their use as part of conducting the trial. Furthermore, the data from laboratory and clinical systems must be viewed as a whole in order to glean real intelligence from the data stream.

Clinipace Worldwide is leading the industry in its approach to clinical trials data collection and just-in-time monitoring using a comprehensive technology platform.

Radke says, “Ultimately, our data-driven solution results in enhanced outcomes for the research sponsors and better relationships with the sites. And, providing cleaner data on time and under budget makes us more successful as a CRO.”

While just-in-time monitoring is an excellent way to increase efficiencies and reduce costs, it doesn’t remove the need for careful on-site monitoring to ensure adherence to protocol and attention to patient safety. However, it can elevate those on-site visits to make them more focused, more strategic and less disruptive to patient care.

Today we announced the addition of Bud Owen, chief financial officer, and Daryl Porter, chief technology officer, to our growing team.  Both Owen and Porter bring substantial experience helping firms grow through technology integration and M&A strategies.

Check out the full press release and their bios.

Welcome to our newest client!  NitricBio has selected the company to manage and deploy multiple studies in support of medical applications of topical nitric oxide gas (gNO).

NitricBio is a mid-stage specialty pharmaceutical company focused on the dermatology and podiatry markets, with two unique drug delivery technologies.  The company awarded Clinipace Worldwide a four-project engagement, including data management, statistical services, and medical writing for two phase 2 trials as well as providing fully-integrated clinical research services to manage and conduct two phase 3 trials.

Read the full release.