Biopharmaceuticals

When you need complex study expertise in large and small molecules, THINK THEOREM.

For more than two decades, Theorem Clinical Research has conducted literally hundreds of trials around the world for some of the world’s largest pharmaceutical and biotechnology companies. We have significant experience with cutting-edge drugs and biologic compounds, in all phases of research, and within numerous therapeutic areas and therapies.

But that’s only part of why you should think Theorem for your complex biopharmaceutical development programs. We’re easy to work with and we get work done. We apply meticulous attention to detail at every stage, starting with the specific challenges inherent in every protocol and not ending until the last biostatistical chart in the final report has been thoroughly reviewed and approved.

Professional project managers make clinical data integrity and open communications between sponsors and study teams central to each project, and every step is checked by clinical quality assurance specialists to ensure that programs are conducted to the highest regulatory, quality and ethical standards.

Biopharmaceutical Development Services

  • Project Management
  • Medical Monitoring
  • Clinical Monitoring
  • Clinical Supplies
  • Data Management
  • Clinical Analytics
  • Regulatory Services
  • Clinical Quality Assurance
  • Pharmacovigilance
  • Medical Writing

Study Start-up Services

  • Feasibility
  • Investigator Recruitment
  • Site Activation
  • Clinical Trial Applications
  • Project Kickoff and Planning Process

Early-Phase Studies

  • First-in-Human
  • Single/Multiple Ascending Dose
  • Drug-Drug Interaction
  • Pharmacokinetics/Pharmacodynamics
  • Food Effect
  • QT/QTc
  • Proof-of-Concept
  • Bioavailability/Bioequivalence

Early-Phase Therapeutic Expertise

  • Cardiovascular
  • Infectious Disease
  • Obstetrics/Gynecology
  • Ophthalmology
  • Respiratory/Pulmonary
  • Vaccines
  • Endocrinology
  • Nephrology
  • Neurology
  • Oncology/Hematology
  • Psychiatry
  • Virology

Phase IIIb/IV Experience

  • Cardiovascular
  • CNS
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genitourinary
  • Hematology
  • Immunology
  • Internal Medicine
  • Musculoskeletal
  • Oncology
  • Psychiatry
  • Radiology
  • Respiratory
  • Surgery
  • Transplant