Clinipace Blog

Making Sense of Rising Oncology Drug Costs

Mark Shapiro is the Vice President of Clinical Development at Clinipace. Although cost control for drugs has been common in countries with socialized medicine or government-payer systems, this issue is now beginning to take center stage here in the United States.  Despite wide coverage in the popular media, such as Dr. Ezekiel Emanuel’s editorial in The New York Times, it was quite striking to see calls for more value-based pricing at the American Society of Clinical Oncology (ASCO) meeting earlier this year. The cost of new drug development is the most-often-cited justification for the high and rising cost of new drugs.  According to the team at the Tufts Center for the Study of Drug Development (CSDD), “developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million.”  That figure includes average out-of-pocket costs of $1,395 million and time costs (expected returns that investors forego while a drug is in development) of $1,163 million.  Relative to their study in 2003, the CSDD estimates that “the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%.” Despite these dramatic costs, it has long been known that pharmaceutical companies price drugs based on value and demand rather than cost, to the extent possible. Of course, this is also subject to formulary negotiations with insurers. Strong biotechnology investment in new oncology therapeutics has partly been justified by the relative price insensitivity of oncology drugs versus other types of therapeutics.  This has led... read more

Clinipace Worldwide Honored in Inc. 500|5000 List for the Sixth Year Running

We’re having a great morning because we’ve been named to Inc. Magazine’s 34th annual Inc. 500|5000 list – for the sixth year running! The Inc. 500|5000 list represents the most comprehensive look at America’s independent entrepreneurs. Started in 1982, this prestigious list of the nation’s most successful private companies has become the hallmark of entrepreneurial success. Clinipace by the numbers: 321% revenue growth from 2011 to 2014 466 jobs added during that period Facts and figures of the 2015 Inc. 5000 Health is the 8th fastest growing industry by aggregate growth rate (147%) North Carolina is the 11th fastest growing state by number of companies (145) “Being recognized by Inc. on a global business level for the sixth year running provides validation for our work. We’re in a very competitive marketplace and we strive to continuously innovate, expand our therapeutic expertise and improve our service delivery model to stay ahead of the curve.” – Jeff Williams, CEO, Clinipace Worldwide This recognition follows our announcement earlier this year of our acquisition of Accovion, a leading European full-service CRO headquartered in Frankfurt, Germany. The move strengthened our operational and therapeutic expertise within Europe and marked our sixth acquisition in as many years. We now have nearly 1,000 global staff members with clinical operations and staff in 39 countries, including North and South America, Europe and Asia. For more information on Inc. and the Inc. 5000 Conference, visit... read more

New eBook: Streamlining the Regulatory Path to Market for Low-Risk Medical Devices

U.S.-based companies dominate the roughly $350 billion global medical device industry, and, as a result, the United States exports more medical devices than it imports. The U.S. Food and Drug Administration (FDA) is responsible for regulating firms that manufacture, repackage, relabel, or import medical devices sold in the United States. It categorizes medical devices into three classes based on the level of regulatory control needed to provide reasonable assurance of safety and effectiveness. Because Class III devices pose a potential for serious risk to humans, all Class III devices must be evaluated in clinical trials before receiving Premarket Approval from the FDA. The clearance process for Class I and II devices is often simpler and commonly does not require novel clinical trial data. Class I and II devices rely mostly on safety and performance data in accordance with quality regulations and consensus standards. Especially when clinical trials are not required, developing Class I and II devices is very feasible for small companies without large capital reserves. However, although the process of FDA clearance for Class I and II medical devices is considered easier, the various submission standards are not always obvious or intuitive, and failure to properly navigate them can lead to wasted resources at best and federal prosecution at worst. In this eBook, we review vital steps in receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process. Download our eBook to learn more about: Understanding the classes and corresponding regulatory controls Confirming your device’s classification Identifying predicate devices already cleared for sale Defining your device’s Intended Use Developing a regulatory and... read more

Clinipace’s UK Office Hosts Harding University Students

Martin Cripps is the Senior Director, Project Management, at Clinipace Worldwide. Last week, our UK office hosted a group of Harding University students and faculty as part of their summer program. This is the fourth year in a row we’ve had the pleasure of hosting this wonderful group from the university. Harding University is located in Searcy, Arkansas, and their summer program brings students to the UK to visit various businesses across multiple sectors. The group of business majors was led by James G. Shelton, PhD, professor of accounting at Harding. In addition to faculty sponsors, the group was also joined by Bruce McLarty, president of Harding University; his wife Anne; and Bryan Burks, dean of the Carter College of Business. During their visit, I presented on the state of research and development in health care, including an industry overview, the phases of clinical development, and an introduction to the business and operations of Clinipace. The presentation reflected current industry trends and our growing geographical footprint and services. I’m always intrigued to learn what the students are most interested in. In previous years, topics of interest have included the phases of clinical development, pricing, and intellectual property. This year, students asked many questions about our TEMPO eClinical platform functionality and our global project operations. They were surprised by the fact that not all companies in our industry have a single data platform. Could this be a sign that technology will be embraced at a faster rate in the future perhaps? As always, I was impressed by the students’ intuitive questions about the pharmaceutical and biotech industry. We would like... read more

Navigating Regulatory Biostatistical Requirements During Trial Analysis and Submission: Post Hoc Analyses

Ron Marks, PhD, serves as CSO and director of biostatistics and is a Clinipace Worldwide cofounder. It was a pleasure to host the webinar “Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle” with my colleague, Scott Miller, PhD, a biostatistician at Clinipace. We reviewed common statistical issues (during trial planning, conduct, analysis, and submission phases) and discussed potential approaches to address these issues. We’ve addressed many excellent questions from attendees regarding the trial planning phase (including protocol deviations, adaptive designs, and alpha spending functions in interim analyses) and the trial conduct phase. In our last posts, we address questions related to trial analysis and submission. If you have any additional thoughts or related questions to ask our experts, please share your comments below. Q: What is the best way to present post hoc analyses to the FDA? A: This is a very interesting question because you can get into really some good discussions about whether or not post hoc analyses are useful. When you write your protocol and especially the SAP, you’re defining all the important planned analyses that are going to take place, which you completely identify before you ever get the database lock and look at your data. That’s clearly what the FDA is going to focus on. But I think you have an opportunity to really use post hoc analyses, especially in Phase II studies more so than in the Phase III studies, to learn more about your product. We have three different stages of analysis: You have the primary analysis, the secondary analysis on your secondary endpoints, and then either exploratory or observational endpoints... read more

Navigating Regulatory Biostatistical Requirements During Trial Planning: Considerations for Adaptive Designs

Scott Miller, PhD, is a biostatistician at Clinipace. Thanks to everyone who tuned in to the webcast “Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle” I recently hosted with my colleague Ron Marks, PhD, Clinipace CSO, director of biostatistics and cofounder. During the presentation, we reviewed common statistical issues (during trial planning, analysis, and submission phases) and discussed potential approaches to address these issues. As a result of a great turnout and many excellent follow-up questions, we decided to address a number of questions in a series of blog posts. Earlier this week we addressed protocol deviations. Today, we’re going to address considerations for adaptive trial designs. If you have any additional thoughts or related questions to ask our experts, please share your comments below. Q: Can you briefly highlight statistical considerations for adaptive trial designs? Adaptive designs are a fairly broad category that covers a wide range of very diverse topics. Essentially, an adaptive design is a pre-specified process which allows for some aspect(s) of a clinical trial (e.g. design, conduct, analysis) to be changed in light of accumulating data. One example is covariate adaptive design, where you have multiple clinically relevant covariates of interest you need to ensure balance on, but there are too many to account for via stratified randomization. Another example is response-adaptive designs. In a standard trial, you would randomize subjects to the treatment arms based on some fixed randomization ratio (like 1:1 or 2:1) and use that ratio all the way through the trial. In some cases, you might want to adjust that ratio over time either to be more statistically precise,... read more

Navigating Regulatory Biostatistical Requirements During Trial Planning: Understanding Protocol Deviations

Ron Marks, PhD, serves as CSO and director of biostatistics and is a Clinipace Worldwide cofounder. Thanks to everyone who tuned in to the webcast “Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle” I recently hosted with my colleague Scott Miller, a biostatistician at Clinipace. During the presentation, we reviewed common statistical issues (during trial planning, conduct, analysis, and submission phases) and discussed potential approaches to address these issues. As a result of a great turnout and many excellent follow-up questions, we decided to address a number of questions in a series of blog posts. In our first few posts, we’ll start with questions regarding trial planning. Check back next week for more great questions around regulatory biostatistical requirements during the trial conduct phase. If you have any additional thoughts or related questions to ask our experts, please share your comments below. Q: Will you please list some common protocol deviations? A: As we discussed in the webinar, protocol deviations are defined as events that occur during your study that don’t go according to the protocol. When protocol deviations occur, they get graded during or at the end of the study to determine whether they are major or minor deviations. Major deviations are handled differently than minor deviations, and if you have a major protocol deviation, you are not part of the per-protocol analysis. All clients want to maximize their per-protocol population because that’s the population that followed the protocol. The more major protocol deviations that occur, the more subjects you lose from that analysis. Typical protocol deviations include assessments or visits that occur outside of a protocol... read more

Clinipace Expert Presenting at DIA 2015

Our head of clinical trial regulatory management in Western and Central Europe, Rainer Porrmann, PhD, will share his expertise at DIA 2015 June 17, in Washington, D.C. His presentation, “Current Situation and Potential Future Development of Regulatory Requirements,” takes place in the medical devices/in vitro diagnostics and combination products track and will provide an overview of the current regulatory requirements for clinical trials for medical devices in Europe and key factors of the proposed new European regulations. Unlike the pharmaceutical side of clinical trials, there is currently no separate regulation or directive that defines the requirements and procedures for medical device trials in detail. This can sometimes lead to some insecurity for non-EU sponsors planning or conducting medical device trials in EEA countries. During his presentation, Rainer will discuss the current regulatory framework in Europe for medical device trials, explaining similarities and differences that show the range of potential variability across Europe. In addition, he will highlight key factors of the proposed new European regulations and provide an update about their development to help prepare for the upcoming changes. Attendees will gain an understanding of key implications for sponsors in regards to trial planning, the submission process, timelines, and conducting clinical trials with medical devices in the EEA. DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life-cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. This annual meeting provides thought leaders, decision makers and patient advocates with the opportunity to collaborate and share knowledge with the top minds in medicine. To learn more about their... read more

Clinipace Expert Named to European Medical Writers Association Executive Committee

A big round of applause to Raquel Billiones, PhD, our senior director and head of medical writing in Europe! She was recently elected into the executive committee of the European Medical Writers Association (EMWA) as honorary secretary. Raquel is a medical writer and life scientist with more than 20 years experience in scientific research and teaching and medical writing. Her expertise lies in preparing and editing regulatory and scientific documents for a wide range of therapeutic areas, including oncology, diabetology, autoimmune diseases and cardiovascular medicine. According to its website, EMWA is a network of professionals that represents, supports and trains medical communicators in Europe. The group is a not-for-profit organization with over 1,000 members from 39 different countries (including 12 countries outside Europe), and includes academics and professionals working in-house or freelance for pharmaceutical and medical communications companies, research institutes, and in the field of scientific journalism. The achievements of our experts continue to amaze us. Congrats,... read more

Clinipace Attends BIO KOREA 2015

Our team recently had the pleasure of attending BIO KOREA 2015, a convention created to share the latest information and technology in the health industry and to establish corporate partnerships among global experts.   As the largest health industry convention in Asia, BIO KOREA hosts about 20,000 participants and 470 companies from 40 nations around the world, providing a networking venue for experts and researchers of the world’s health industry.     Growth for Asia’s pharmaceutical and clinical trials markets is continuing at double-digit rates, with particularly strong growth predicted for China, South Korea, Taiwan, and Singapore through 2017. Clinipace has long understood the importance of this region, and in anticipation of the high demand by clients for localized operations, the company expanded its Asian presence with the acquisition of Choice Pharma. The merger extended Clinipace’s global footprint to include 20 operational offices in 15 countries, including new offices in Taiwan, China, Hong Kong, South Korea, Vietnam, Singapore, and Malaysia. If you’re interested in information on therapeutic areas in Asia and the benefits of clinical trials in the region, feel free to watch our recorded webcast and download the related... read more

Clinipace Expert to Present at PharmaSUG Annual Conference

Our manager of statistical programming, Dirk Spruck, will share his expertise at the annual PharmaSUG conference tomorrow, May 19, in Orlando, Fla. He will be presenting on the paper, “Qualification Process for Standard Scripts in the Open Source Repository with Cloud Services,” with Hanming Tu of Accenture, Dante Di Tommaso of Roche, Christopher Hurley of MMS Holdings, Inc., and Nancy Brucken of inventive Health. The paper describes the steps, platform and progress of initiating a qualification process for standard scripts hosted in the Google Code repository with cloud services. The open source repository is used as a collaborative development platform for hosting the specialized programs to be used as analytic tools for clinical trial research, reporting, and analysis through cloud services. The presentation will include how to access the repository, how to contribute to the repository and more importantly how to ensure the quality of the scripts being stored in the repository. PharmaSUG’s mission is to provide a forum for the exchange of information and the promotion of new ideas concerning the use of software and tools in the clinical research, pharmaceutical, and healthcare industries. To learn more about their annual conference or register, visit the their website. Leave us a comment or contact our team if you plan to be in attendance at the PharmaSUG annual conference. We would love to connect you with Dirk to learn more about how statistical programming applies to your clinical trial. In addition, if you’d like more information on statistical requirements for clinical trials, Clinipace will be hosting a free webcast, “Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle,” on Thursday,... read more

New Webcast: Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle

Regulatory authorities, such as the FDA, aim to assure the safety and efficacy of drugs, biological products and medical devices by overseeing all aspects of a clinical trial lifecycle. Sufficient thought in the trial planning stage reduces time required in developing later submissions and responding to enquiries from regulatory authorities at the trial submission stage. Constant monitoring and addressing protocol issues as they occur also reduces time and issues at study completion. Are you working with a partner with the expertise and technological resources to assist with this process and help the process go as smoothly as possible? Tune in live on Thursday, May 28th, 2015 11:30 am ET to learn: Common statistical issues (during trial planning, conduct, analysis and submission phases) Case study examples of common issues Recommended approach to address common issues to regulatory authority’s satisfaction Enabling technology Presented by: Ron Marks, PhD Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide Ron is a skilled, knowledgeable biostatistician and biomedical researcher, having served on the University of Florida faculty for 30 years in the Division of Biostatistics. In 2004, he retired from the university, and now devotes his time fully to building Clinipace Worldwide and assisting in product design, trial execution and customer support. He has an extensive background in design, analysis and reporting of large-scale clinical trials and other research studies, and has been a lead clinical trial consultant with a number of large pharmaceutical companies including Unilever, Braun, Procter & Gamble and GSK. Scott Miller, PhD Biostatistician, Clinipace Worldwide As a biostatistician with Clinipace, Scott works on trials ranging from Phase 1 to 4, providing... read more

Clinipace Co-Founders Named E&Y Entrepreneur of the Year® 2015 Southeast Finalists

Please join us in congratulating Jeff Williams, CEO and co-founder, and Chris Porter, president and co-founder, on being named one of three finalists in the Health Care & Life Sciences category of the Ernst & Young Entrepreneur Of The Year 2015 Southeast Program! The prestigious awards program recognizes entrepreneurs who demonstrate excellence and extraordinary success in areas such as innovation, financial performance and personal commitment to their businesses and communities. The Southeast region includes Alabama, Georgia, North Carolina, South Carolina and Tennessee. “We are honored to be recognized as finalists for the Southeast region of this prestigious award. Clinipace was built on the fundamental belief of improving clinical trial operations in terms of quality and cost, and we’re proud to say this is the foundation upon which Clinipace has grown to nearly 1,000 employees. It has been a truly remarkable journey that would not be possible without the dedication and expertise of our employees.” -Jeff Williams, CEO “It is truly exciting to be recognized for our entrepreneurial spirit, which extends far beyond Jeff and myself and can be seen throughout the company. We are grateful to be surrounded by forward-thinking team members who have proven to be invaluable to the company’s continuing success.” -Chris Porter, president Now in its 29th year, the Entrepreneur Of The Year Program has expanded globally to recognize company builders in over 145 cities and in more than 60 countries throughout the world. To read today’s announcement, click... read more

Where Does mHealth Fit in the Regulatory Path-to-Market for Low-Risk Medical Devices?

Charlotte Baker is the Senior Director, Regulatory & Strategic Development, Medical Devices, at Clinipace Worldwide. The webinar I hosted, Streamlining the Regulatory Path to Market for Low Risk Medical Devices, was particularly useful for emerging or venture-backed firms new to the regulated medical device industry. We reviewed vital steps to receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process. Following the webinar, we addressed some of the excellent questions from attendees in a series of blog posts around clinical trial data, understanding classes and the application process. In this post, we’re addressing questions related to mHealth. If you have any additional thoughts or related questions to ask our experts, please share your comments below. Q: Can you give some insights on how wearable technology will be managed within the current regulatory framework? A: I’m assuming the question is referring to wearables such as the watches people wear to measure their heartbeats, pulse and respiration. This is a very new area in technology, and the FDA has been made aware of that and is considering some guidance around these types of devices. First and foremost, does this type of wearable meet the definition of a medical device? Does it cure, mitigate or treat disease? If it does classify as a medical device, more than likely, you will be required to at least conform to some basics of the Quality System Regulation and perhaps a 510k notification. Without knowing what the wearable is, what it does or how it functions, it’s difficult to say whether or not you need a 510k. Q: What is... read more

Clinipace Expert to Speak at the ACRP 2015 Global Conference

Our very own Clinical Trials Manager, Deborah Rosenfelder, will share her expertise at the ACRP 2015 Global Conference this Saturday, April 25th, in Salt Lake City, Utah. She will be speaking on the panel, “Walk the Talk: Implementing Risk-Based Monitoring,” with Marilyn Cassell, Project Manager at Biomet Orthopedics, and Valerie Willetts, Manager, Clinical Operations at PAREXEL International. Deborah has shared her more than 20 years of expertise in cardiology and drug and device research as a co-author of the Clinipace eBook, “Key Issues in Clinical Development for Interventional Cardiovascular Devices” and co-presenter of the related webinar, “5 Steps to Success for Your Cardiovascular Medical Device Trial.” The ACRP panel discussion will be focused on translating theory into practice. Attendees will learn methods for applying risk-based theories to their own projects as panelists review case studies where risk-based methodology has been applied. The panel will explore ways in which actual studies have applied risk-based methodology, and how studies have used tools/templates to implement a risk-based monitoring strategy and optimize individual site performance. This panel is targeted to coordinators/site coordinators (CRCs), monitors (CRAs), principal investigators, research nurses and site management personnel. In addition, audience participation will be encouraged throughout the session with the use of smart phone technology. The Association of Clinical Research Professionals (ACRP) Global Conference & Exhibition is the largest annual clinical research conference solely focused on the conduct of clinical trials. The conference provides clinical research professionals with more than 100 educational sessions addressing more than a dozen topics critical to the clinical research process, and provides many opportunities for networking with other clinical research professionals. To learn... read more