MDS Pharma Services’ protocol scientists are familiar with the regulations from the FDA, Health Canada, EMEA and other regulatory agencies. Our protocol scientists work closely with the local institutional review boards and ethics committees that serve our phase I clinics, to facilitate protocol approval. Additionally, the protocol scientists actively solicit input from our pharmacokinetic/pharmacodynamic, statistical, and clinic staff, to ensure a successful clinical study.

We can provide you with a protocol for a bioequivalence study for rapid study start-up. We also have experience developing protocols for other clinical pharmacology studies. We can evaluate alternative study designs, perform sample size calculations, make recommendations on randomization and blinding, advise on PK/PD parameter selection, and aid in the selection of appropriate sampling times.

Types of study protocols written:

• Bioavailability
• Bioequivalence
• Single ascending dose
• Multiple ascending dose
• Hepatic impairment
• Renal impairment
• Drug-drug interaction
• Thorough QT/QTc studies
• PK/PD evaluations

Early Clinical Research

Phase I-IIa

Bioequivalence Studies

PK/PD

Study Design and Protocol Development

Data Management

Statistical Analysis

PK/PD Analysis

Medical Writing and Reporting

Modeling and Simulation

Consultation