editable text http://www.clinipace.com Sat, 25 May 2013 01:09:41 -0400 Sat, 25 May 2013 01:09:41 -0400 Following Clinipace’s Boosting Enrollment in Oncology Trials webcast, we wanted to share some of our thoughts on the need for protocol simplification especially in early phase oncology trials, as well as field some related attendee questions. http://www.clinipace.com/protocol-simplifications-lead-to-increased-oncology-trial-enrollment Barb Geiger Thu, 23 May 2013 11:55:00 -0400 Despite its rich pipeline, cardiovascular device innovation is slowing.  In this webcast, you’ll gain insight into the cardiovascular device research pipeline and approval trends.  In addition, we’ll outline five key steps you need to take to be successful in your global CV medical device trials.  http://www.clinipace.com/cardiovascular-medical-device-trial-5-steps-to-success-new-webcast Emily Nichols Tue, 21 May 2013 12:58:00 -0400 Within this series of posts, Mike Trudnak, Daryl Porter, and I want to first describe the common language associated with clouds and potential benefits to organizations that use them.  We will then expose a newer framework that changes the discussion from the traditional public/private/hybrid clouds to another model of describing cloud formations.  We will end the series with a deeper look at what cloud formation best illustrates Clinipace Worldwide as a cloud provider. http://www.clinipace.com/forming-clouds-in-pharma-–-an-introduction-to-the-cloud Lisa Jamba Mon, 20 May 2013 10:54:00 -0400 Drug resistance is reaching crisis proportions in the US and globally, challenging sponsors to continuously develop new approaches to the treatment of infections.  The incidence of infection with multi-drug resistant (MDR) gram-negative bacteria is on the rise, particularly among patients in healthcare settings.  http://www.clinipace.com/infectious-disease-drug-development-multi-resistant-bacterial-threat Stuart Byham Thu, 16 May 2013 09:38:00 -0400 The Triangle Business Journal and accounting giant BDO have honored Clinipace with one of its inaugural Life Sciences Awards.  The awards recognize both individuals and research organizations that are breaking ground in this field. http://www.clinipace.com/clinipace-recipient-of-a-triangle-business-journal-2013-life-sciences-award Emily Nichols Fri, 10 May 2013 13:05:00 -0400 I wanted to tackle an attendee question submitted during the One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm webcast.  The question asks: What do you mean by data queries in real time? What is the difference with a traditional EDC where queries are issued also online? http://www.clinipace.com/data-queries-in-real-time-with-clinipaces-proprietary-tempo-eclinical-platform Heather Bristol Wed, 08 May 2013 11:56:00 -0400 Join our panel of experts for an interactive presentation to learn more about the brewing controversy around whether a US-style, centralized approval process will ultimately help or hurt the medical device industry in the EU. http://www.clinipace.com/eu-medical-device-regulations-new-webcast Emily Nichols Tue, 07 May 2013 13:35:00 -0400 On April 30th, we held our most popular live webcast to-date, “Trends and Considerations in Global Infectious Disease Drug Development.” Attendees learned about current trends in global clinical development of infectious disease therapies http://www.clinipace.com/on-demand-webcast-available-trends-considerations-in-global-infectious-disease-drug-development Emily Nichols Thu, 02 May 2013 16:19:00 -0400 Following the recent One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm webcast, I collaborated with Lisa Jamba (Service Line Architecture Specialist) and Mike Trudnak (Executive Director, IT) to answer attendee questions.   http://www.clinipace.com/clinipaces-proprietary-tempo-eclinical-platform-security-confidentiality-and-privacy Daryl Porter Tue, 30 Apr 2013 13:27:00 -0400 I recently co-presented a webcast on increasing study efficiency through the use of technology with my colleague, Crista Casey. We received several questions related to maintaining compliance for the preparation and storage of Study Documents while managing trials via a digital eClinical platform. http://www.clinipace.com/study-documents-maintaining-compliance-with-a-digital-cro Cindy Venendaal Tue, 23 Apr 2013 16:38:00 -0400 Following the “Best Practices for Boosting Enrollment in Oncology Trials” webcast  - I wanted to explore a topic that received a lot of interest and feedback – the use of social media and technology for patient recruitment. http://www.clinipace.com/the-role-of-social-media-and-technology-in-patient-recruitment-for-oncology-clinical-trials Barb Geiger Fri, 19 Apr 2013 14:49:00 -0400 It was a pleasure to team with my industry colleague, Chris Mackay, Project Director, Early Phase Pharma, University of Kansas Cancer Center, for a recent webcast on “Best Practices for Boosting Enrollment in Oncology Trials”. We received a lot of great feedback during and after the presentation, so we’re working on a series of blog posts to address many of the questions received. http://www.clinipace.com/oncology-clinical-trial-design-traditional-vs-adaptive Barb Geiger Thu, 18 Apr 2013 10:11:00 -0400 Today, I was quoted widely in a story In-PharmaTechnologist.com published titled US API Imports for Clinical Trials Now Require Effective IND, Expert Says. The story came as a result of my recent “Outsourcing Clinical Supplies Manufacturing: Navigating US Import Laws” webcast.   http://www.clinipace.com/changes-to-us-api-import-strategies Nikolas Burlew Wed, 17 Apr 2013 10:49:00 -0400 Our next webcast tackles how we can come together to help meet the continuing, ever-changing threat from infectious disease. Learn about the emerging trends in infectious disease drug development, advanced technologies, and related regulatory considerations that can affect outcomes of this global threat. http://www.clinipace.com/new-webcast-trends-and-considerations-in-global-infectious-disease-drug-development Emily Nichols Tue, 09 Apr 2013 16:12:00 -0400 I led a webcast on March 27th entitled “Outsourcing Clinical Supplies Manufacturing: Navigating US Import Laws.” During the webcast, we asked attendees several polling questions and I wanted to share the results from one that looks at their experiences to date with Port of Entry import restrictions. http://www.clinipace.com/clinical-supplies-manufacturing-–-port-of-entry-import-restrictions Nikolas Burlew Fri, 05 Apr 2013 12:14:00 -0400 I will be speaking at the Colorado BioScience Association’s BIOBOOT CAMP 2013.  This annual event is a 2-day program for start-up company executives. Attendees learn valuable information from experienced entrepreneurs http://www.clinipace.com/speaking-at-colorado-bioscience-association’s-bioboot-camp-2013 Brenda Fielding Tue, 02 Apr 2013 11:37:00 -0400 Clinipace Worldwide is sponsoring the Rocky Mountain Chapter of the International Society of Pharmaceutical Engineering’s Spring Educational Meeting and Dinner.   http://www.clinipace.com/clinipace-sponsors-ispe’s-rocky-mountain-chapter’s-spring-educational-meeting-and-dinner Emily Nichols Thu, 28 Mar 2013 09:52:00 -0400 An estimated 3% of US adult cancer patients participate in clinical trials.  The low participation rate is a major bottleneck in developing new cancer treatments.  Clearly a key factor in progress toward better treatment and prognosis in adult oncology lies in improving participation rates.  http://www.clinipace.com/boosting-enrollment-in-oncology-trials-new-webcast Emily Nichols Fri, 22 Mar 2013 15:00:00 -0400 Throughout the "One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm" webcast - we asked attendees several polling questions.  The first question: How many different databases do you currently utilize to manage a clinical trial? http://www.clinipace.com/the-dcro-streamlining-16-databases-into-one-single-platform Chris Porter Wed, 20 Mar 2013 10:43:00 -0400 During the “Risk-Based Clinical Trial Monitoring: A Technology Amplified Approach” webcast, attendees submitted a few questions related to our proprietary TEMPO™ eClinical platform.  Several of my colleagues assisted in sharing their insight and providing answers to the questions    http://www.clinipace.com/risk-based-trial-monitoring-with-clinipace’s-proprietary-tempo-eclinical-platform John Parnell Tue, 19 Mar 2013 09:40:00 -0400 The significant growth of clinical supply imports to the US has resulted in more rigorous interpretation and enforcement of import laws and regulations to ensure supply chain quality.  Here are some of the key challenges alongside my recommended solutions. http://www.clinipace.com/5-ways-to-avoid-costly-delays-from-us-clinical-supply-import-laws Nikolas Burlew Fri, 15 Mar 2013 14:30:00 -0400 We got a number of great questions during our recent webcast, Risk-Based Clinical Trial Monitoring: A Technology Amplified Approach. As such, I wanted to take a few moments to provide feedback. http://www.clinipace.com/risk-based-monitoring-–-answers-to-webcast-attendee-questions Deborah Rosenfelder Thu, 14 Mar 2013 15:24:00 -0400 We had a great turnout for our live webcast on February 28th and we have created supplemental information as well as a corresponding downloadable eBook titled, “Mitigating the Challenges of Clinical Trial Monitoring: A Technology Amplified Approach.”  http://www.clinipace.com/risk-based-clinical-trial-monitoring-new-ebook-and-supplemental-information-from-webcast Emily Nichols Wed, 13 Mar 2013 13:15:00 -0400 Recently, we have fielded a lot of great questions about our TEMPO™ eClinical Platform and how it benefits clinical trial management. Our upcoming webcast entitled One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm on March 12 http://www.clinipace.com/how-technology-impacts-clinical-trial-management Emily Nichols Fri, 08 Mar 2013 15:28:00 -0500 Clinipace’s Nikolas Burlew, Vice President of Quality Systems, will be presenting an interactive webcast that examines changes to laws governing the import of clinical trial supplies into the US and best practices for overcoming hurdles. http://www.clinipace.com/outsourcing-clinical-supplies-manufacturing-navigating-us-import-laws-new-webcast Emily Nichols Wed, 06 Mar 2013 10:18:00 -0500 In a February 2013 Clinipace-sponsored webcast on “The Joys and Woes of Clinical Trial Start-Up,” participants were polled on what percentage of total trial costs they devoted to study start-up.  The wide range of responses was intriguing and got us thinking about how these results compare to the industry as a whole.  http://www.clinipace.com/aiming-at-a-moving-target-defining-the-“ideal”-study-start-up-cost Tenley Koepnick Fri, 01 Mar 2013 11:56:00 -0500 We had a great turnout for the February 14th webcast on “The Joys and Woes of Clinical Start-Up: A Global Perspective.”  During the live event, we polled participants to learn what part of the global start-up process was their greatest pain point http://www.clinipace.com/global-clinical-trial-start-up-we-feel-your-pain Tenley Koepnick Wed, 27 Feb 2013 15:25:00 -0500 Site monitoring has traditionally been one of the most expensive aspects of conducting clinical trials. Costs of site monitoring have been estimated to be 25% to 30% of the overall costs of a clinical trial. The high cost is in large part due to a traditional approach of having site monitors travel  http://www.clinipace.com/keeping-site-monitors-closer-to-home Monika Frey Mon, 25 Feb 2013 12:53:00 -0500 Given the complexity and uniqueness of clinical trials, no single monitoring plan works for every study. Recently the Food and Drug Administration (FDA) has started encouraging sponsors to move from traditional, all on-site monitoring to using a risk-based approach. http://www.clinipace.com/risk-based-remote-monitoring-of-study-conduct-and-patient-data Marie Hanley Fri, 22 Feb 2013 13:38:00 -0500 On March 12, Clinipace experts will take part in an interactive webcast entitled: One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm. Participants will learn about the many benefits of using a technology-amplified approach http://www.clinipace.com/better-clinical-trial-management-the-rise-of-the-dcro-new-webcast Emily Nichols Fri, 22 Feb 2013 10:49:00 -0500