JEFFREY M.

GARNER
19102 Cloister Lake Lane
Boca Raton, FL 33498
561-482-3173 office
561-504-9172 cell
jgf9b318@westpost.net
Multi Therapeutic Senior Regional CRA/ Senior Projects Manager/GCP Auditor
Pharmaceutical and Medical Device Consultant

SUMMARY:
a 25 years clinical research experience as a Clinical Research Associate includi
ng 13 years working with sponsor companies
a Worked on over 500 Pharmaceutical and Medical Device programs including Phases
I-IV drug trials and series I,II, and III device programs
a Diverse therapeutic experience including Respiratory in the areas of COPD and
Asthma
a Involved in the design of CRFas, Consent forms, and experienced in protocol de
sign and review
a Recently completed 164 hours of continuing education
a Mentored junior Clinical Research Associates
a Conducted aNave Site Traininga for sites that have never been involved in Clin
ical Research
THERAPEUTIC AREAS:
a Respiratory: Asthma and Chronic Obstructive Pulmonary Disease.
a CNS: Alzheimers, Parkinsons (Cortical Brain Stimulator), MS, GAD,
a Gastroenterology: Ulcers, Diabetic Stasis, GERD and IPPUAD, Colitis, and Stoma
Care.
a Anti-Infective: UTI, URI, Otitis Media, Post-Surgical and Sepsis.
a Pain Management: Migraine, Post Dental Extraction Pain. Post Operative Pain, D
ysmenorrhrea and RA/OA.
a Endocrine: Obesity and Diabetes Type l and 2, Diabetic Neuropathy
a Cardiovascular: Hypertension, Congestive Heart Failure and Hypercholesterolemi
a.
a Psychiatry: Social Phobia, GAD and Obsessive-Compulsive Disorder.
a Dermatology: Psoriasis.
a Ophthalmology: Dry Eye, Allergic Rhinitis/Red Eye, Conjunctivitis and Catarac
t.
a Oncology: Pediatric Oncology, Melanoma, Anti-Emetic and Small Intestines/Colon
Cancer, Lung, Prostate and Breast.
a Renal: Nephropathy

RESUME:
PROFESSIONAL EXPERIENCE:
SCION, Miami, FL August 2009 to January 2010
Regional Senior CRA Consultant
a Performed a Randomized Double Blind, Parallel Stratified, Multi-Center Study c
omparing the Safety and Efficacy of two Proprietary Pressure bandages in PIC uni
ts on Angiography studies.
a Conducted for a aWhite Papera which was in support of pending litigation for m
arketing rights.
FIBROGEN, San Francisco, CA November 2008 to May 2009
Regional Senior CRA Consultant
a Involved in the implementation of aA Randomized Double-blind, Placebo Controll
ed, Phase I, Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 i
n Subjects with Type I or Type II Diabetes Mellitus and Diabetic Nephropathy on
Background ACEi and/or ARB Therapya. This Investigational product is a new and
unique Monoclonal Antibody which is being produced and researched solely by the
Biotech Group XXXXXXX.
a The majority of these sites were in a hospital setting due to the severity of
the subjectsa condition.
ABBOTT PHARMACEUTICALS, Cranbury, NJ March 2008 to August 2008
Regional Senior CRA Consultant
a Completed an independent field audit of 80 sites conducted by two clients that
participated in a Phase III Asthma/COPD clinical trial in which the sponsor was
trying to get to Data Lock.
a After ascertaining what the problem was, conducted 2 meetings with the Directo
r of Global Operations for the project and initiated a plan to address all the p
rotocol and source document deviations.
a Sponsor was able to enter their data for analysis and the project was able to
be completed.
I3 RESEARCH, RTP, NC October 2006 to May 20
08
Regional Senior CRA Consultant
a Monitored 6 sites at various locations in Puerto Rico on a large 900 site, 12,
000 subject Phase III Type I and II Diabetes Mellitus clinical trial.
a The majority of the sites were aresearch navea so responsible for conducting a
n 18 hour training course to teach the site personnel how to comply with GCP/ICH
guidelines.
a Training course dealt with study notes, record retention, ICF presentation to
the subject, and Investigational Product handling and accountability among other
things.
a Reviewed clinical data to insure accuracy, completion and integrity of data.
a Compared source documentation against case report forms.
a Maintained a working knowledge and assure compliance with the GCP, ICH and Spo
nsors SOPas.
a Assured the supply and account for the disposition of clinical materials.
a Reported/disseminated all adverse reaction information in a timely manner as d
efined by the Sponsor and the FDA.
a Attended Investigator Meetings.
a Responsible for GCP and SOP training of site staff members.
a Completed monitoring and other routine reports as required.
a Qualified potential investigators.
a Interacted with investigators to obtain pre-study administrative packets.
a Initiated investigational sites.
a Conducted investigational site termination visits.
a Served as lead contact for the study team and clinical sites.
a Presented at the investigators meeting.
a Conducted report review.
PHARMACEUTICAL CLINICAL RESEARCH CO., Boca Raton, Florida
1997 to 2006
President, Regional Senior CRA/Pharmaceutical Consultant
a Reviewed clinical data to insure accuracy, completion and integrity of data.
a Compared source documentation against case report forms.
a Maintained a working knowledge and assure compliance with the GCP, ICH and Spo
nsors SOPas.
a Assured the supply and account for the disposition of clinical materials.
a Reported/disseminated all adverse reaction information in a timely manner as d
efined by the Sponsor and the FDA.
a Attended Investigator Meetings.
a Responsible for GCP and SOP training of site staff members.
a Completed monitoring and other routine reports as required.
a Qualified potential investigators.
a Interacted with investigators to obtain pre-study administrative packets.
a Initiated investigational sites.
a Conducted investigational site termination visits.
a Served as lead contact for the study team and clinical sites.
a Presented at the investigators meeting.
a Conducted report review.
PFDA LTD. (Formerly Pharmaceutical Food and Drugs Associates), Plainview, New Yo
rk 1981 to 1997
Vice President of Clinical Research, Clinical Research Associate I & II 1990 to
1997
a Monitored of clinical investigative sites.
a Adhered to ICH guidelines and FDA regulations.
a Adhered to protocol guidelines.
a Responsible for case report form review.
a Responsible for source document verification.
a Provided drug and study supply accountability.
a Verified regulatory documentation.
a Completed monitoring reports.
a Facilitated communication between Sites and Sponsor.
a Resolved data communication with sites.
a Responsible for study close out visits.
Pharmaceutical Food and Drugs Associates, Roslyn, New York 1
981 to1990
Clinical Research Associate I
a Participated in study start-up process.
a Assisted with site selection.
a Conducted study qualification visits.
a Ensured integrity of clinical data against source documentation.
a Conducted site visit reports.
a Ensured drug and site material accountability.
a Reviewed and maintained regulatory documentation.
a Investigated any queries between site and the sponsor.
a Conducted site close out visit.

EDUCATION:
Adelphi University, Long Island, NY
May 1985
Master of Arts, Sociology
Institute for Applied Pharmaceutical Sciences, East Brunswick, NJ
1982
Teaching Associate
Tulane University, New Orleans, LA
May 1981
Bachelor of Arts, Sociology and Political Science, Deanas List

COMPUTER SKILLS:
Microsoft Windows XP, Word, Word perfect and various EDC systems such as Inform,
 among others.
CLINICAL EXPERIENCE:
CNS AND ANTI-DEPRESSION
a To determine the efficacy of (XXX) in the relief of signs and symptoms of anxi
ety associated with cardiovascular disease or associated with cardiovascular sym
ptoms in the absence of demonstrable organic disease.
a Short-term Double Blind - To determine the clinical efficacy, safety, and pati
ents acceptance of (XXX) in the symptomatic treatment of psychoneurotic patients
displaying symptoms of anxiety of at least a moderate degree with or without ac
companying somatization or depression.
a Valium - To compare the efficacy of (XXX) and Valium (Diazepam) in patients in
a family practice setting who exhibit manifestations of psychoneurotic anxiety
and depressive disorders.
a The study will compare anxiolytic and anti-depressant effects of (XXX) with th
ose of a (YYYY) plus (XXXX) combination drug in treating patients with a diagnos
is of mixed depression and anxiety in association with subjective gastrointestin
al complaints.
a To evaluate the effect of (XXXX) on anxiety associated with organic disease or
the normal reactive anxiety seen in office practice (50 patients).
a The evaluation of (XXXX) compared to (YYYY) and a placebo in the treatment of
symptoms of nervous tension associated with the Menopausal Syndrome (96 patients
).
a The evaluation of (XXXX) tablets compared to (YYYY) and of placebo in the trea
tment of anxiety tension states due to exaggerated autonomic response (25 patien
ts).
a Oral Vistaril vs. Placebo on the induction and maintenance of sleep in patient
s scheduled for surgery on the following morning.
a Short-term Double Blind - To determine the clinical efficacy, and safety of (X
XXX) in the symptomatic treatment of psychoneurotic patients displaying symptoms
of anxiety with or without accompanying somatization (50 patients).
a Worked on Bipolar, and Manic Depression as well as SAD (Social Anxiety Disorde
r).
a Worked with mothers who have experienced post-partum depression in three, 12 w
eek clinical trials assessing XXXX. One of these products was a controlled rele
ase product and another two were new indications for SSRI's. I am very familiar
with the DSMV IV and the rating scales utilized to assess subjects at baseline
as well as during the run of the study. I have used HNDs and PLMS assessments a
s well as other rating scales listed in the DSMV1. I have also worked on the re
cent clinical which assessed Elan's use of Luvox, the very first SSRI, but in an
extended release formulation in both 100 mg CR and 150mg CR vs. immediate relea
se Luvox in decompansated OCD and Hyper Manic patients. These last clinical last
ed 12 weeks in duration and looked at both efficacy and safety. A sub-set of th
e group looked at those subjects above the age of 65 who showed they had a longe
r time of clearance time. I don't know if the group looked at adolescent or pedi
atric populations due to the black Box warning currently being listed for any Ps
ychotropic in the treatment of subjects in this group.
a Worked with Dr. Layton Mcurdy who was Chief of Psychiatry and Dean of the Medi
cal School at the University of South Carolina.
PULMUNARY
In the area of COPD, I recently completed an audit of a 40 site clinical trial e
ntitled:
a A randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Mu
lti-Center, 12-Week Stydt, Comparing the Safety and Efficacy of Fluticason and F
ormoterol Combination (FlutiForm 100/10 ug twice daily) in a Single Inhaler (Sky
ePharma HFA pMDI) with the Administration of Placebo or Fluticasone (250 ug twic
e daily) and Formoterol (10 ug twice daily) Alone in Adolescent and Adult Patien
ts with Moderate to Severe Asthma.
GASTROENTEROLOGY
I have been involved in over 50 clinical trials in the GI area. The following si
x protocols are an example of some of the GI work I have been involved with:
a A Double a" Blind randomized placebo controlled crossover Acid Reflux/G.E.R.D.
, 16 patients study utilizing the Oxford Medilog 5000 system to assess reflux ph
. 14-hour assessment A.H. Robbins.
a A Double-Blind, placebo controlled crossover, comparison study for the relief
of symptoms of Gastric Distress; Heartburn, Acid Indigestion, Sour Stomach and f
ullness/Bloating 60 patients five sessions (Warner-Lambert, Richardson Vick, Pro
ctor & Gamble, A.H. Robbins, Eaton Norwich, and Stuart Pharmaceutical).
a Double-Blind two-way crossover Acid Reflux, 16 patients, and three-hour assess
ment - Del Avionics Nasal Catheter System.
a Treatment of Acute Duodenal Ulcer with an H2 a" Receptor Antagonist or Placebo
12 weeks, three Endoscopies confirmation (four centers 48 patients).
a The safety and efficacy of Prostaglandin E1 on Duodenal Ulcer Disease; a doubl
e blind, placebo-controlled study.
a Effect of Prostaglandin El on Duodenal Ulcer Recurrence; a double-blind, place
bo-controlled study following Prostaglandin El double-blind Ulcer Healing study.
ANTI-INFFECTIVES
a A Double-Blind Study of the efficacy and safety of Floxacillin in the treatmen
t of skin and skin structure infections when compared to Dicloxacillan (four sit
es, 96 subjects) Generic Group.
a Comparison of the Safety and Efficacy of (SCH 39720) with that of Cefaclor in
the treatment of acute Otitis Media in Children (five sites, 100 subjects).
a Involved in the study of anti-infectives for the treatment of URI, LRI, UTI, P
neumonia, and Post-Surgical Infection.
a A multicenter open-label non-comparative study of Parenteral (XXXX) in the tre
atment of hospitalized pediatric patients with infections caused by susceptible
bacteria (ten centers, 40 subjects per center).
a A study to determine the pharmacokinetics, safety, and efficacy to (XXXX) in t
he treatment of infections where Pseudomonas Aeruginose is a clinically signific
ant pathogen (patients two to 15 years), four centers (enrollment open).
a A comparative study of two doses of A-46811, with Amino glycosides in patients
with urinary tract infections due to Pseudomonas Aeruginosa.
a Comparative Aminoglycoies- Amikacin Sulfate, (YYYY) Phase II. 8 centers (50 su
bjects per center).
a Comparative safety and efficacy of A-49759 (ODMF) in patients with urinary tra
ct infections - Phase II 8 centers, (35 subjects per center).
a Comparative safety and efficacy of A-49759 (ODMF) and (XXXX) in patients with
lower respiratory tract infections - Phase II 8 centers (35 subjects per center)
.
a A multicenter open, non-comparative study of Parenteral (XXXX) (cephalosporin)
in the treatment of hospitalized patients with infections caused by susceptible
bacteria. Phase III, 15 centers, (30 subjects per center).
a A multicenter, observer blind, comparative study of Oral Ru 965 and Erythromyc
in Ethylsuccinate (EES) in patients with infections caused by susceptible bacter
ia - Phase II, 18 centers, (30 subjects per center).
a A double-blind study of the efficacy and safety of B-1105 in the treatment of
skin structure infections when compared to (YYYY) 10 centers (20 subjects per ce
nter).
a Comparison of the efficacy and safety of SCH 39720, with that of Cefaclor in t
he treatment of Acute Otitus Media in children two to 12 years of age 2 centers
(48 subjects).
ANALGESICS
a A double a" blind multicenter Aspirin controlled 12 week study to determine th
e efficacy and safety of (NSAID X) in patients with Rheumatoid Arthritis (5 cent
ers, 125 subjects).
a Single a"blind evaluation of the analgesic effect and safety of XXXX in the tr
eatment of patients with chronic pain (3 centers, 150 subjects).
a Double a"blind evaluation of the analgesic effect and safety of XXXX in pati
ents with muscle contraction (or tension) headaches (100 subjects, 2 sites).
a An open- label study to determine the safe and effective dosage of XXXX in pat
ients with chronic degenerative disease (Osteoarthritis) of the knee or hip join
t (1 site, 30 subjects).
a Double-blind evaluation of the analgesic effect of YYYY in patients with post-
meniscectomy pain (3 sites, 90 subjects).
a A double blind multicenter study to compare the efficacy and safety of XXXX ag
ainst placebo in the treatment of patients with primary dysmenorrhea (2 sites, 1
00 subjects).
a Evaluation of the analgesic effect of XXXX in patients with postpartum uterine
cramp or post episiotomy pain (3 sites, 120 subjects).
a A double-blind evaluation of the analgesic effects of (NSAID X) in patients wi
th pain following oral surgery. Third and Fourth molar extraction (2 sites, 90 s
ubjects).
a To evaluate the safety and efficacy of (NSAID Q) in comparison with aspirin an
d placebo in patients with post- partum uterine cramps (2 sites 60 subjects).
a To evaluate the safety and efficacy of (NSAID K), 250,375, and 500 mgs in subj
ects with acute episodes of rheumatoid arthritis (3 sites, 90 subject).
a To evaluate the safety and efficacy of (NSAID K) 250, 375, and 500 mgs in subj
ects with acute episodes of osteoarthritis (3 sites, 90 subjects).
a Assessment of the efficacy and safety of single oral doses of A-10281 in the t
reatment of post dental extraction pain (2 sites, 100 subjects).
a Preliminary protocol for developing and standardizing a low back pain model fo
r use in studying the efficacy of a muscle / relaxant analgesic combination agen
t (1 site, 20 subjects).
a A double blind preliminary study to assess the safety and toleration of XXXX a
dministered as a 100mg single oral dose to healthy volunteers (1 site, 15 subjec
ts).
a A double blind preliminary group study to assess the efficacy and safety of va
rious doses of AAAA in the relief of post a" cesarean section pain (160 subjects
, University South Carolina).
CARDIOVASCULAR
a A Multinational, Multicenter, Open-Label, Comparison of Intravenous, aXXXX Ver
sus Sodium Nitroprusside In Patients With Severe Hypertension. Protocol 82526/D1
101/WW.
a A comparison of the efficacy of XXXX and YYYY in the treatment of hypertension
and hypertensive cardiovascular disease of the mild to moderate variety (30 pat
ients).
a A multicenter comparison of XXXX and YYYY/XXXX combination to evaluate the saf
ety of XXXX (2 mg/0.5 mg) as a fixed combination vs. YYYY (0.5 mg) alone in the
treatment of essential hypertension (24 patients).
a A comparison of the efficacy of XXXX with the YYYY in the treatment of hyperte
nsion and/or hypertensive cardiovascular disease of mild to moderate severity 16
week trial (30 patients).
a A comparison of the efficacy of XXXX with that of Renese-R (polythiazide plus
reserpine) in lowering blood pressure in patients with diagnosed hypertension. 1
6-week trial (50 patients) four-week placebo washout.
a A multicenter comparison of XXXX and YYYY polythiazide combination to evaluate
the safety and efficacy of (2 mg/0.5) as a fixed combination vs. XXXX/YYYY (0.5
mg) alone in the treatment of essential hypertension (50 patients).
a A comparison study of XXXX vs. YYYY in hypertension to compare the efficacy of
XXXX with that of YYYY in the treatment of essential hypertension An open, rand
omized crossover evaluation (50 patients).
a A collaborative comparison evaluation of the side effects profile of XXXX 2 mg
and YYYY 1 mg given b.i.d. with 25, in patients with essential hypertension 15
investigators (200 patients).
a A double blind randomized study to evaluate the effects of Long-Term Antihyper
tensive Therapy on Plasma Lipids and Lipoproteins and Quality of Life (AHR-4458)
(ten investigators, 210 patients).
a A Multinational, Multicenter, Open-Label, Comparison of Intravenous, aXXXX Ver
sus YYYY in Patients with severe hypertension (150 subjects).
a A 12 week double blind, placebo controlled study to determine the efficacy and
safety of orally administered (CI-906) HCL in the treatment of congestive heart
failure (5 investigators, 50 patients).
a An open label 12-month period treatment with oral XXXX for the treatment of co
ngestive heart failure (five investigators, 50 patients).
a A four week double-blind, placebo controlled multicenter study to determine th
e efficacy and safety of twice-a-day orally administered (CI-775) dosing regimen
in patients with Angina Pectoris undergoing exercise tolerance testing, (8 inve
stigators, 92 subjects).
a Efficacy and Safety of Core-Coat (Bay k5552) ten, 20, and 30, mg QD Vs. Placeb
o in Patients with Stable Exertional Angina Pectoris (2 investigators, 32 subjec
ts).
ENDOCRONOLOGY
Diabetes Type II
a LAF237A231190- A multi-center, randomized, open-label, active controlled, para
llel arm study to compare the efficacy of 12 weeks of treatment with Vildaglipti
n 100 mg, qd, to thiazolidinedione (TZD) as add-on therapy in patients with Type
II diabetes inadequately controlled with metformin monothereapy in a community-
based practice setting. 600 centers, 12,000 patients-National Study (November 1
5, 2006 to January 1, 2008), I3 Research, Regional CRA, Florida and Puerto Rico.
ONCOLOGY
Solid Mass Tumor Phase II and III
a Phase II Trial to Compare the Effectiveness of XXX to Tamoxifen For Prevention
Of Breast Cancer Recurrence In Post-Menopausal Women With Ductal Carcinoma In S
ITU (DCIS) of The Breast.
Leukemia
a Myeoblastic Leukemia Phase IIA and IIB.
a Carcinoma of the Prostate Phase IIIA.
a Solid Pseudopapillary Tumor of the Pancreas.
a A Randomized Placebo Controlled Study of XXXX Plus XXXX In Patients With Local
ly Advanced, Unrestrictable Or Metastatic Pancreatic Cancer.
a Phase III Trial Comparing Four Regimens Of Chemotherapy For First-Line Treatm
ent of Advanced or Metastatic Pancreatic Adenocarcinoma.

CONTINUING EDUCATION:
The following courses were reviewed and tested on during 2006 to 2008:

a Introduction to SOP Training

a An Introduction to Six Sigma
a eClinical 7.5 Module One Course I-Introduction
a eClinical 7.5 Module One Course II-Navigation
a eClinical 7.5 Module Five Course IV-Monitoring Visits
a eClinical 7.5 Module Five Course V Course-Monitoring Visit Report Tracking
a eClinical 7.5 Module Eight Course One-Reports
a Electronic Records and Signatures
a Field Monitoring Orientation
a Fraud and Misconduct SOP Training
a Introduction to Siebel Clinical for CRAaS
a Selection of Investigative Sites
a Pre-Study Site Visit
a Monitoring Visit
a Source Data Verification
a New Employee Orientation
a Essential Documents I
a Essential Documents II
a Essential Documents III
a Informed Consent Development
a Trial Master File Consent and Management
a Distribution of Signatures for Clinical Study Personnel
a Clinical Trial Safety Surveillance: Serious Adverse Processing I
a Clinical Trial Safety Surveillance: Serious Adverse Processing II
a Source Data Verification Process
a Time Tracking for CRAaS
a Investigational Product Relabeling at site
a Central Files
a Ethics and Integrity Program Overview
a Handling Sensitive Data and Electronic Media
a Work Lesson I- Ethics and Integrity Overview
a Work Lesson II-Privacy Overview
a Work Lesson III-Protecting Company Intellectual Property
a Work Lesson IV-Records Management Awareness
a Work Lesson VII-Information Security
a Work Lesson VIII-Conflicts of Interest
a Work Lesson VIIII-Foreign Corrupt Practices Act (FCPA)
a Harassment Prevention Training for Employees
a Ingenix Privacy Policy Overview
a LearnWell Training for Employees
a Distribution, Maintenance and Handling of SOPas
a Documentation of Signatures for Clinical Study Personnel
a Retention of Records Relating to Clinical Projects
a Documentation Practices
a Telephone Communications with non-i3 personnel
a Vendor Qualification
a Vendor Identification and Review for Qualification
a Business Continuity
a Potential Fraud and Misconduct (For-Cause) Investigations
a Inspection by Regulatory Agencies I
a Inspection by Regulatory Agencies II
a Training and Development I
a Training and Development II
a Processing Contract or Work Order Changes
a Compliance with 21 CFR Part 11-1
a Compliance with 21 CFR Part 11-2
a Audits by i3 by Sponsors
a Corrective and Preventive Action Quality Process
a Physical and Logical System Security I
a Physical and Logical System Security II
a Informed Consent Preparation
a Investigator Site Audits
a Filling and Archiving of Quality Assurance Audits I
a Filling and Archiving of Quality Assurance Audits II
a Reporting and Distribution of Quality Assurance Audits
a Ingenix Quality Assurance Policy
a Quality Assurance Policy
a Global Pharmacovigilance Policy
a Right the First Time and Quality Program
a Siebel eClinical Version 7.8 Upgrade- Module I
a Siebel eClinical Version 7.8 Upgrade- Module II
a Selection of Investigative Sites
a Site Initiation Visit
a Close-Out Visit
a Source Data Verification
a Case Report Form Retrieval and Transmittal I
a Case Report Form Retrieval and Transmittal II
a Investigational Product Accountability
a Selection of an Investigation Product Storage and Shipment Family
a Selection of Central Laboratory
a Selection of Central Institution Review Board
a Selection of Central Institution Review Board or Ethics Committee
a Financial Disclosure Policy I
a Financial Disclosure Policy II
a Translation of Essential Documents
a Translation of Essential Documents
a Operations Manual
a Computer System Validation Committee (CSVC)
a Data Lock and Freeze
a Serious Adverse Event Reconciliation I
a Serious Adverse Event Reconciliation II
a Format, Creation, Revision and Approval of SOPas
a eClinical 7.5 Instructions for Training
a GCP Series Module I: Introduction to Good Clinical Practices
a GCP Series Module III: Informed Consent
a GCP Series Module IV: Drug Safety
a GCP Series Module V: Ethical Review Boards
a GCP Series Module VI: Financial Disclosure
a Generating Reports in Ellipsis Time Tracking
a Global Master File and Transmittal Form Attachments
a In the Company of Specialists: The New Employee Orientation Program
a Policy on progress Documentation
a i3 Quality Policy
a Monitoring Visit
a Selection of an Investigational Product Storage and Shipment Facility
a Selection of a Central Laboratory
a Audits of i3 by Sponsors