Clinical Trials

Beijing, China






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Phase I

Your product development plans deserve the best integrated program of research services available - so choose PHDS. With pressure to substantially increase numbers of trial participants, increased scrutiny on product safety and stringent regulatory controls throughout the world, PHDS is ready to partner and bring to the fore the expertise, resources and insight required to guide you through the complex and challenging course of biopharmaceutical development.


Integrated development

Our integrated clinical development services are unique to PHDS. Acquire the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global clinical trials. 

Your success is our sole mission at PHDS. The value proposition PHDS cultivates is expertise leveraged over a broad range of services, our financial strength, and a passionate and talented team of experts to help you make faster, better decisions.

Clinical study protocols continue to grow more complex, requiring larger capacity, specific patient populations, complex procedures and sample requirements, multiple endpoints, and flexible protocol design.  At PHDS these complex trial designs are a special focus for our clinical research units.

Your phase I PHDS team of scientists and clinicians closely monitor clinical testing, including preliminary evaluation of drug safety, tolerance and pharmacokinetics. As more information on your drug candidate becomes available, we'll scrutinize development progress and deliver additional data for decisions including drug-drug interactions, food effect and special population studies.


Phase I studies and services:

l  First-in-Human and complex study designs

ü  SAD-MAD, including food effect and patient arms

ü  Adaptive clinical protocol design

ü  Model development and biomarker capabilities

l  Cardiac safety including definitive QTc (TQT)

l  Integrated Human AME Studies

ü  Micro-dose

ü  Light-labeled

ü  Traditional

l  Ethnic bridging studies

l  Sleep studies

l  Standardized Clinical Pharmacology studies

ü  Absolute bioavailability

ü  Age and gender

ü  Bioavailability (BA)

ü  Bioequivalence (BE)

ü  Dose proportionality

ü  Drug/drug interaction

ü  Food effect

ü  Pharmacodynamics (PD)

ü  Pharmacokinetics (PK)

l  Vaccines


Phase I Clinic Expertise

Dedicated project teams implement each project assigned to the clinic. Teams are led by project managers and are composed of staff specialized in recruitment, study conduct and case report form completion. Teams work closely with their clients to assure all protocol requirements are met. For continuity, teams are routinely assigned to work with the same sponsors.

Full-time medical professionals provide around-the-clock care of study volunteers. The staff is fully qualified and experienced in numerous study designs, therapeutic areas and routes of administration.

To ensure menu consistency among volunteers in each study, a qualified caterer manages the onsite food service and a registered dietician is available to prepare specialized diets for protocols that require them.


Phase I Clinic Study Types

l  First administration into man

l  Bioequivalence

l  Bioavailability

l  Dose ascending safety

l  Drug interaction

l  Food effect pharmacokinetic and pharmacodynamic studies


Therapeutic Areas

l  Analgesia

l  Cardiovascular indications

l  Central nervous system (CNS)

l  Dermatology

l  Endocrinology

l  Gastroenterology

l  HIV

l  Infectious disease

l  Neurology

l  Oncology

l  Respiratory indication

l  Vaccines

l  Urology


Routes of Administration

l  IV, IM, and subcutaneous injections

l  Inhalant

l  Intranasal

l  Ophthalmic

l  Oral, buccal and sublingual

l  Suppository

l  Transdermal

l  Topical