PPD can support you at any point in your journey, whether you are starting in early phase all the way through post-approval and commercialization
You are looking for increased assurance of a successful asset development strategy
Will your clinical strategy help you achieve development goals on time?
Will your data meet approval and reimbursement requirements?
Are budgets planned out as efficiently as possible?
Our teams help you answer these questions and meet your development targets, helping you and your investors rest easier.
That Makes PPD a Leading CRO
Consulting: Regulatory Consultation, Therapeutic Expertise, Competitive Landscape Analysis, Rare Diseases and Pediatrics
PPD Laboratories: Central Lab, GMP Lab, Bioanalytical Lab, Vaccine Sciences Lab, Biomarkers Lab
TRACK RECORD OF SUCCESS
35-year track record
30,000+ clinical professionals globally
Worked on all of the top 10 selling drugs of 2019
Conducted >2,500 clinical trials in the past 5 years
Global network of tradition and wholly-owned sites
PPD Labs worked on >7,600 compounds in the past 5 years
Involved in 87 global drug approvals in 2019
Clinical
Labs
Most Therapeutic Areas and Modalities
STUDIES
HEMATOLOGY/ONCOLOGY
670
RARE DISEASES1
545
INFECTIOUS DISEASE
355
NEUROSCIENCE2
326
VACCINES
220
IMMUNOLOGY
202
RESPIRATORY
174
CELL AND GENE THERAPY1
130
ENDOCRINOLOGY / METABOLIC
127
GASTROINTESTINAL
108
CARDIOVASCULAR
62
DERMATOLOGY
OPHTHALMOLOGY
59
CRITICAL CARE
52
GENITO-UROLOGIC
42
WOMEN’S HEALTH
23
OTHER
(1) Indications within rare disease and CGT cover multiple therapeutic areas. (2) Includes neurology and pain.
Optimize Your Development Strategy and Preparedness for Approval and Reimbursement
Database analytic
Chart reviews, surveys, registries
REMS, RMPs, PASS/PAES
Manuscripts, publication planning
REMS and IIIb/IV document support
Standard/global response letters; product FAQ docs
Payer research, ad boards
Value and evidence strategy
Evidence communication and submission support
Indirect treatment comparisons, lit reviews
Economic, epid. modeling
Clinical trial, disease simulation
COA/PRO development, validation and application
Health utility studies, preference elicitation
Benefit-risk assessment
Compassionate use and extended/expanded access
Investigator-sponsored/initiated trials
IIIb/IV studies
Dedicated infrastructure, processes, focused exclusively on early development services and clinical pharmacology projects.
Early development expertise and key project team members located locally to ensure timely communication and understand of relevant regulations and processes, with access to global experts across all Therapeutic Areas, as well as PIs.
A unique combination of wholly owned clinical research units (CRUs) and global access to a network of 29 specialty sites ensures optimal site selection for each study in your pipeline, based on site experience, availability and requested timelines.
Optimized strategies and expedited decision making.
Trials moving more rapidly and seamlessly from early clinical to proof of concept and beyond.
Pain
Dermatology
GI
Hematology
Opthamology
Respiratory
Infectious Disease
Neurology
Genito
Immunology
Oncology
Psychiatry/Psychology
Cardiovascular
Endocrinology/Metabolic
Women's Health
Musculoskeletal
Other
Experience
No. of Studies
No. of Subjects
Bioavailability
69
2,501
Bioequivalence
47
2,379
Biosimilars
20 (12 NHV)
2,364
Drug-Drug Interaction
83
2,442
Food Effect
1,856
Pharmacokinetics
245
7,575
Pharmacodynamics
67
2,037
Single Ascending Dose
48
2,415
Multiple Ascending Dose
27
546
TQT
1,100
*600+ Phase I studies involving 10,000+ patients and healthy volunteers conducted in the past five years.
