The shortest distance between 2 points

Transcription

1 From Development Plan to Product Approval The shortest distance between 2 points Therapeutically Specialized Clinical Drug Development

2 The shortest distance between two points is always the direct route Taking a drug from development plan to regulatory approval requires the most efficient, cost-effective pathway possible. Too much is at stake for anything but a direct route. Yet, today s pharmaceutical and biotech companies face unprecedented complexities that can derail and delay drug development. In each therapeutic class, the challenges are immense and unique. The shortest distance to product approval requires top scientists who are therapeutically focused. Specialized regulatory insight from the start. Selection of top investigators. Quick recruitment of the right patients the first time from a global population. A stable, specialized clinical operations team. Flawless data. Innovative technology. There is no time for wrong turns. Medpace is a global, research-based drug development company with deep expertise in the therapeutic areas of: Cardiology Metabolism Oncology Medpace takes a drug from development plan to product approval with unmatched expediency. And for Phase III clinical trials, no one matches this level of expertise. Only Medpace provides the advantage of focus. The shortest distance requires

3 Focus Medpace combines expertise in science, industry, operations, and regulatory strategy to provide the most efficient and effective pathway to drug approval.

4 Led by top scientists and regulatory specialists Deep medical expertise Medpace has assembled an extraordinary hands-on leadership team of medical and regulatory experts. These highly regarded industry leaders provide sponsors with therapeutic expertise that streamlines each phase. Each Medpace scientist is deeply committed to a core therapeutic area. These specialists have played a vital role in developing new treatments and research technologies in their fields. They quickly become trusted advisors and can be involved at any level requested by the client. Many sponsors tap their expertise for clinical decisions that would otherwise be forwarded to the sponsor further trimming timetables. Focused regulatory expertise Former government regulatory officials provide sponsors with valuable foresight. Beginning right from program design, they maintain an unwavering focus on the goal of regulatory approval. They have helped Medpace achieve an enviable track record of regulatory submissions worldwide. Real-world industry expertise Medpace experts understand the need to balance excellent data with timely recruitment. Because they consistently work in a single field of research, they have built productive, long-term relationships with investigators, saving sponsors from expensive, extended enrollment periods and disruptive protocol amendments. The shortest distance requires

5 EXPERTS We have the experts to get a study done most efficiently with less sponsor oversight. That s a clear advantage.

6 Recruiting the right patient populations worldwide Patient recruitment is the greatest obstacle in clinical trials today. Finding the right patient populations has fueled the rapid international growth of Medpace. With operations in over 40 countries, we are well positioned to meet changing client needs. Medpace offices are located in Africa, Asia / Pacific, Australia, China, Eastern Europe, India, Latin America, the Middle East, North America, and Western Europe. Medpace is always focused on making every global study cost-effective and efficient. That s why we maintain start-up and efficiency metrics for each country where we conduct trials. We assist sponsors in prioritizing international sites, not only by patient populations, but also by start-up speed and relative cost. The shortest distance requires reaching a

7 global Population The right size CRO is important. And so is the right kind of knowledge in the right parts of the world.

8 On-target, on-time clinical operations Medpace studies start quickly, run smoothly, meet enrollment timelines, and require less oversight from sponsors. The first-patient and last-patient screenings are typically ahead of project timelines. This operational excellence is possible only because Medpace clinical operations teams all over the world are therapeutically focused and uniquely organized for maximum efficiencies. Dedicated team for quick start-up At Medpace, a dedicated start-up team launches the program quickly and efficiently. The sole job of this team is to rapidly prepare sites to screen patients. The team helps sponsors choose the sites that meet budgets and timelines. Clinical trial managers who foresee issues Centrally-based Medpace clinical trial managers are experts at running complex clinical trials. Additionally, they are experts in their therapeutic areas. Therefore, they identify problems and correct them before they can impact the study. Stable and knowledgeable Clinical Research Associates Medpace uses a centralized clinical research model in the US, which results in greater commitment to quality and to the company. Our low turnover rate less than 10 percent in the last five years creates valuable consistency for sponsors. Clinical Research Associates (CRAs) are typically assigned just two protocols each. They gain an in-depth understanding of the therapeutic area and protocol, which allows them to communicate knowledgeably with investigators. I n other parts of the world, Medpace CRAs are regionally-based, enabling them to better understand the culture, language, and regulatory environment where they work. The shortest distance requires

9 Medpace clinical operations teams are experts in their therapeutic classes. There s no better way to jumpstart a study, avoid problems, and deliver timely results. a specialized team

10 Imagepace exemplifies the Medpace commitment to innovation Imagepace applies the same high Medpace standards and expertise to the imaging aspects of studies. Imagepace provides centralized core lab capabilities for managing standard, as well as innovative, imaging modalities, including carotid intima-media thickness (cimt), MRI, CT, and DEXA. Standardized procedures and scientific and operational expertise connect imaging requirements with other clinical components of the study. Imagepace is the global leader in cimt imaging and reading. With a network of imaging sites and centralized reading centers, Imagepace utilizes standardized cimt technology to conduct clinical trials with a cimt endpoint. Imagepace is leading the way on the new approval path for cardiovascular compounds. From ground-breaking research into lipids...to the latest in imaging, we re proud of our contributions to our fields of research. The shortest

11 distance requires i nnovation

12 Medpace is not just about getting your study done. We get your product approved. Flawless data that meets regulatory needs Medical writing Quality assurance Committed to quality. Responsive to timelines. Medpace data management staff handle clinical trial data in a manner that is cost-efficient, secure, and regulatory compliant. Sponsors highly value the context and perspective that pervade every aspect of our data management. There is simply no one more qualified for medical writing in our therapeutic areas. In-depth expertise ensures the development of meaningful and comprehensive reports and marketing applications. Documents are submission-ready and fully compliant with regulatory guidelines. The quality assurance team is an independent unit within Medpace and reports directly to the Chief Executive Officer. This team conducts independent audits to evaluate company and site compliance with procedures and regulations. Audits allow for early intervention and corrective action when necessary. Biostatistics The skilled Medpace biostatistics group develops and executes comprehensive data analysis plans and is engaged in trial management from study inception to the final report. In addition, the biostatistics group provides statistical methodology recommendations and programming expertise. This group lays the foundation for on-time, high-quality deliverables. Data analysis is performed using industry-standard SAS software. Medpace Core ECG Laboratory The Medpace Core ECG laboratory provides state-of-the-art, standardized ECG equipment and centralized reading to support Phase I IV clinical trials. All ECGs are interpreted by a board certified cardiologist, and the ECG data are incorporated into submission-ready electronic databases. ClinTrak ClinTrak is Medpace s fully customizable study management system, which tracks all aspects of studies. Sponsors have nearly real-time, Web-based access to data. Programmers are on location, and customized reports, updates, and adjustments are efficient and seamless to sites. Unlike its competitors, ClinTrak is infinitely powerful and versatile, interfacing with labs as an integral part of each study. The shortest distance requires

13 data: TIMELY, accurate, relevant

14 The Medpace Group of Companies Medpace Reference Laboratories Medpace Reference Laboratories (MRL) is a central laboratory with locations in Leuven, Belgium and Cincinnati, USA. The expertise of MRL includes coagulation, cardiovascular diseases, oncology, lipids, diabetes, and other metabolic diseases. The management staff averages 25 years experience. Medpace Reference Laboratories offer clients analytical support during all stages of drug development. Experienced, knowledgeable, professional staff provide full coordination of project management. Services include: state-of-the-art instrumentation and methods, which are identical at sites on both continents; production and shipping of specimen collection kits; CCDC Part III lipid standardization; formally correlated testing menus; customized reporting and delivery options to accommodate international requirements; long-term archival specimen storage; and appropriate quality assurance and accreditation. Imagepace Imagepace provides centralized core lab capabilities for managing standard, as well as innovative, imaging modality including cimt, MRI, CT, and DEXA. Standardized procedures and scientific and operational expertise connect imaging requirements with other clinical components of the study. With a network of imaging sites and centralized reading centers, Imagepace is the global leader in clinical trials with a cimt endpoint. Medpace Clinical Pharmacology Medpace Clinical Pharmacology focuses on Phase I and IIa confined / controlled pharmacokinetic / pharmacodynamic studies utilizing special patient populations, with first-in-man capability. Medpace Clinical Pharmacology utilizes the Mortara 12-lead telemetry system, enabling the conduct of thorough QT / QTc studies, as well as other cardiac surveillance services.

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16 The Medpace Group of Companies has offices in Africa, Asia / Pacific, Australia, China, Eastern Europe, India, Latin America, the Middle East, North America, and Western Europe. The North American, European, and Asian / Pacific headquarters are listed below. For a comprehensive listing of Medpace offices, please visit our Web sites. Medpace Americas 4620 Wesley Avenue Cincinnati, OH USA Toll Free: Tel: Fax: Imagepace 4620 Wesley Avenue Cincinnati, OH USA Toll Free: Tel: Fax: Medpace Clinical Pharmacology 4685 Forest Avenue Suite B Cincinnati, OH USA Tel: Fax: Medpace Reference Laboratories 4620 Wesley Avenue Cincinnati, OH USA Toll Free: Tel: Fax: Medpace Europe Rivium Boulevard 102b 2909 LK Capelle Aan Den IJssel / Rotterdam Netherlands Tel: Fax: Imagepace Europe Rivium Boulevard 102b 2909 LK Capelle Aan Den IJssel / Rotterdam Netherlands Tel: Fax: Medpace Reference Laboratories Europe Technologielaan 19 B-3001 Leuven Belgium Tel: Fax: Medpace Asia / Pacific Unit #01-02 Nordic European Centre 3 International Business Park Singapore Singapore Tel: Fax: T h e a d v a n t a g e o f f o c u s