October 1, 2009October 1, 2009

An Introduction to Clinical ResearchAn Introduction to Clinical Research

What is Clinical Research?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.

Clinical Research Center of ExcellenceClinical 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.

The R&D ProcessThe R&D Process

                                                                                     

The Clinical Research IndustryThe Clinical Research Industry

Sponsor

CRO

ElectronicApplication Provider

Drug PackagingIVRSCentral LabSMO

Investigator

Study Participant

Clinical Research StepsClinical Research Steps

Study Design

StudyInitiation

Study Enrollment

Study Conduction

StudyCloseout

Drug Accountability

Study Monitoring

Adverse Events Reporting

Data Collection

Clinical Trials – US Study SitesClinical Trials – US Study Sites

12008 Total Studies image - www.clinicaltrials.gov 8/09

KSR Clinical Research – since 1996KSR 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

Clinical Research CompetenciesClinical 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

CoE Recruiting CompetenciesCoE 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

Clinical Research ExpertiseClinical 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.