Kendle International Inc

Assured global delivery

Kendle’s global clinical development business is focused on five regions – North America, Europe, Asia/Pacific, Latin America and Africa – to meet customer needs. With a global approach to international and national trials ensures rapid site start-up and delivery of high-quality results on time. Offering tailored, integrated solutions to global patient recruitment and retention challenges that combine the right sites with the right approach and the right message

Kendle's scope is greater than just recruitment. They also focus on retention by keeping investigators and patients motivated throughout each study.

Committed project teams

Providing highly experienced Project Leaders and multi-functional study teams who will work with you proactively and creatively to accelerate the clinical development process.

Project Leaders are given clear authority and accountability for study performance and are involved in a project from the onset. Because they have primary responsibility for customer relationships and repeat business, they carefully plan study strategy, drive the development of project-specific operating procedures and control team assignments and activities.

Experience across all major therapeutic areasr

Consistent contribute to the development, approval and life cycle management of innovative therapies for a broad range of medical conditions. Global and local therapeutic expertise includes oncology, central nervous system (CNS), cardiovascular, inflammatory and respiratory diseases, endocrinology, analgesia, women’s health, vaccines and dermatology. Focusing our therapeutic offerings on market needs and already are aligned with the top areas expected to represent more than 70 percent of worldwide drug sales through 2013: oncology, antibiotics/antivirals, cardiology, arthritis/inflammation, respiratory and diabetes.¹

Proprietary software solutions

Range of proprietary suite of software products, TrialWare®, enables clinical trial data to be processed faster through excellence in automated workflow, parallel processing and standardization. The TrialWare® family of technology includes:

TrialBase• ®, our database management system

TrialWatch• ®, our global project management information system

TriaLine• ®, our interactive voice response patient randomization system

TrialWeb• ®, our Web-based communications and information sharing tool

TriAlert• ®, our coding enhancement feature

TrialMD• ®, our investigator feasibility and information management system

TrialEAS• ™, our Web-based electronic alternative to paper-based adjudication of clinical endpoints

Preview Kendle’s capabilities

Early Stage – Comprehensive global services, from First-in-Human through Phase IIA/proof-of-concept studies, with world-leading psychopharmacology expertise, in addition to bioequivalence and pharmacokinetic studies for established compounds

Clinical Development – Phase II-III clinical research services to biopharmaceutical companies across a broad spectrum of therapeutic areas

Regulatory Affairs and Quality – Strategic clinical development planning, regulatory submissions, clinical trial regulatory affairs, non-clinical consulting, CMC development and pharmacovigilance/safety services

Biometrics – Clinical data management, biostatistics and eClinical (EDC) services

Late Phase – Phase IIIB/IV studies; health economics and outcomes research; product/disease registries and observational studies; and scientific events and medical education services

Kendle fast facts

Services provided in more than 100 countries

Customers include 40 of the world’s top 50 biopharmaceutical companies

54 clinical development locations in 31 countries, spanning six continents

Named to FORTUNE Magazine’s list of 100 Fastest-Growing Companies for 2008

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