Clinical Pharmacology

Clinical Pharmacology

As a highly flexible, fit-for-purpose clinical development CRO, CD BioSciences provides full-service clinical pharmacology supports to facilitate your early phase programs. With renowned services, clinical staff and accessibility, we are dedicated to working with you to advance your clinical pharmacology studies for biologics and small molecules. We are committed to partnering with you at the moment of truth.

Expert Guidance for Your Clinical Pharmacology Studies

It’s a great milestone to introduce a drug into the human for the first time. To help you make go/no-go decisions, we provide full-service clinical pharmacology support to your drug development programs. We mainly focus on two aspects of the programs, scientific integrity and human subject safety. At CD BioSciences, we are capable to conduct clinical trials in healthy volunteers, patients, and special populations to fit your specific drug development program. Our patient database capabilities span a broad range of therapeutic areas, including cardiovascular disease, infectious disease, oncology disease, and etc. With extensive experience in full-service clinical laboratory and sample processing procedures, we have successfully delivered thousands of reports. We are highly experienced in the following services (but are not limited to) for clinical pharmacology studies.

• First-in-human single ascending dose and multiple ascending dose (SAD and MAD)
• Dose proportionality
• Drug-drug interaction (DDI)
• Adaptive protocol design
• Cardiac safety including definitive QTc/thorough QT (TQT)
• Food effect
• Human ADME
• Clinical pharmacokinetics/pharmacodynamics (PK/PD)
• Bioequivalence
• Bioavailability
• Special patient populations

Partnering with CD BioSciences to Find a Solution for Your Clinical Pharmacology Uncommon Studies

In addition, we are dedicated to providing support for uncommon clinical pharmacology procedures. We are experienced in handling specialty clinical pharmacology procedures including:

• Serial and continuous cerebrospinal fluid (CSF) collection
• CNS cognitive evaluation
• Inhalation/intranasal delivery
• Intratympanic injection
• Drug-alcohol interaction
• Female OC-drug interaction
• Respiratory dose administration

Full-service Early Phase Clinical Trial Program Support

We are fully dedicated to your early phase clinical trial program with support executed by our professionals. A full spectrum of early development services include:

• Protocol design and early phase concept and program development
• Protocol writing
• Regulatory and pre-IND/IND meeting consultation services
• Scientific consultation
• Multi-site feasibility support based upon established QA-approved site network
• Dedicated Phase I/early development project management group
• Phase 1 focused data management
• Biostatistics and statistical design planning specific to early development studies
• Pharmacokinetics
• Clinical monitoring
• Pharmacovigilance
• Site management
• Medical writing

CD BioSciences is dedicated to providing full-service clinical pharmacology studies to evaluate drug safety, tolerance, pharmacokinetics, and etc., delivering unique insights for go/no-go decisions. If you are ready to take a deeper dive into our extensive experience with specific patient populations or full-service clinical pharmacology procedures, please feel free to contact us to learn more.