This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.

1. October 1, 2009 An Introduction to Clinical Research

2. What is Clinical Research? Clinical research is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers.

3. Clinical Research Center of Excellence Team of Consultants dedicated to sourcing, recruiting and placing clinical research, regulatory and medical affairs, data management and biostatistics professionals with pharmaceutical, biotechnology, and medical device companies, as well as with research facilities, contract research and site management organizations across the Americas.

4. The R&D Process

5. The Clinical Research Industry Sponsor CRO Electronic Application Provider Drug Packaging IVRS Central Lab SMO Investigator Study Participant

6. Clinical Research Steps Study Design Study Initiation Study Enrollment Study Conduction Study Closeout Drug Accountability Study Monitoring Adverse Events Reporting Data Collection

7. Clinical Trials – US Study Sites 12008 Total Studies image - www.clinicaltrials.gov 8/09

8. KSR Clinical Research – since 1996 Recruiting Clinical Research professionals since 1996 Center of Excellence (CoE) Re-launched August , 2008 Experienced management, seasoned recruiters Collectively, over 100 years recruiting, clinical research and HR consulting experience Workforce Augmentation (Temporary and Temporary-to-Hire), Executive Search, Project Management Support Phase I to post marketing Recruiters are position-focused (e.g. Regulatory Affairs, Clinical Affairs/Operations, Data Management) Teams aligned geographically Team approach Recruiter collaboration on flexible workforce Select and submit most qualified candidates Share candidate, salary and market intelligence to focus continuing sourcing efforts Partner with Kelly’s network of local operations Proactive sourcing (i.e. recruiters source and network daily) via referral, networking, social media, niche partners, direct marketing and traditional methods Active membership in Clinical Research & Professional Organizations including: DIA, ACRP, SoCRA, AMWA, AmStat and HBA Customer Care team dedicated to service, follow-up and support

9. Clinical Research Competencies Early phase to post marketing support Industry Experience Pharmaceutical Medical and Diagnostic Device Biotechnology Contract (Clinical) Research Organizations Site Management Organizations Academic Research Institutions

10. CoE Recruiting Competencies Clinical Operations / Clinical Affairs Clinical Research Associates (In-house and Regional) Study, Site and Trial Managers Project and Program Managers Medical Directors Data Management, Statistical Programming and Biostatistics Global Librarians Clinical Data Management Associates and Clinical Data Managers Statistical Programmers (SAS, Oracle Clinical) Biostatisticians, Managers and Directors of Biostatistics Medical and Regulatory Affairs Regulatory Affairs Associates and Managers Drug and Product Safety Specialists Pharmacovigilance and Safety Surveillance Specialists, Managers GCP Auditors Medical and Submissions Writers Additional: Clinical Supplies Managers, Contracts Managers, Business Development Managers

11. Clinical Research Expertise Therapeutic area experience Oncology, Cardiovascular, Diabetes/Endocrinology, Allergy/Rhinitis, Asthma/Pulmonary, CNS, Infectious Diseases, Vaccines, Immunology, Acute Care, etc. Device experience Cardiovascular (Rhythm Management, Atrial Fibrillation, Stent), Orthopedic implant, Neuromodulation, Imaging, Respiratory, Diabetes Diagnostic, Oncology Diagnostic, Ophthalmology, etc.