Bioequivalence/Bioavailability Studies and Phase I/IIa Clinical Trials

Bio Pharma Services Inc. provides a wide range of Early Stage Clinical Trial services under the management of highly trained and knowledgeable team of professionals. All clinical trials are conducted in accordance with Good Clinical Practices, ICH, Federal Regulations and rigorous Standard Operating Procedures.

We offer:

• Experienced research team of scientists, physicians, CRAs, nurses and technicians
• Rapid subject recruitment
• Access to Healthy volunteers, special populations, patient populations
• A focus on volunteer and patient safety
• Regulatory compliance
• Fast turn-around time
• Strict adherence to the protocol
• Large capacity Phase I/IIa clinical facilities which have been audited
  by major regulatory agencies, including the US FDA, Health Canada and UK MHRA
• One-stop shop services for BE studies and Phase I/IIa Clinical Trials

Services Overview

• Protocol Development and Review

  • Bioequivalence (BE) studies
  • Bioavailability (BA) studies
  • Clinical Pharmacokinetic (PK) studies
  • Safety and tolerability studies
  • First-in-human studies
  • First-in-patient studies (proof of concept)
  • Drug-Drug interactions studies
  • Japanese Bridging studies/ Japanese BE studies
  • Ascending dose studies (Single Ascending Dose/Multiple Ascending Dose)
  • Food effect studies
  • PK/ PD studies
  • Clinical endpoint studies

• Clinical Execution of the Protocol

  • Toronto site: US FDA-inspected, UK MHRA-inspected, and Health Canada-inspected clinical facility, with 3 independent mixed-gender 48-64 bed units (174 beds) capable of short term & long term confinement, plus a 14-bed First-in-Man Phase I/IIA clinic
  • Karachi site: Pakistan MOH-inspected clinical facility with 3 independent mixed-gender 40-bed units (120 beds) capable of short term & long term confinement
  • Extensive database of healthy male and female volunteers, post-menopausal females
  • Extensive network of investigators in close proximity to the clinical facility in Toronto
  • Experienced physicians, nurses, phlebotomists and technicians dedicated to subject safety and data integrity
  • Standard Operating Procedures meet strict international standards set by
  ICH, US FDA, Health Canada, EMA
  • Overall project management for the entire study, providing one point of contact
  for clients
  • Safety monitoring
  • Every protocol is reviewed by an independent local Ethics review board and
  Health Canada
  • Purchase of reference standards
  • Sourcing of specialized tests and equipment
  • Vendor management
  • Partnering with sites, and specialty laboratories

• Partner with Bioanalytical Laboratory

  • Method development, validation and transfer
  • High throughput analysis of biological specimens
  • Electronic data transfer and interim reporting

• Pharmacokinetic/Pharmacodynamic and Statistical Analysis

  • Statistical analysis and interpretation of analytical and pharmacokinetic data
  • Pharmacokinetic modeling
  • Population pharmacokinetics
  • Analysis of clinical endpoints
  • Consultation

• Integrated Report Writing and Electronic Submissions

  • Compliant with ICH, and requirements of USA, EMA, TPD and
  other regulatory agencies as required
  • CTD format reports
  • eCTD
  • Post-submission regulatory follow-up

• Quality Assurance Auditing

  • With independent reporting to management

• Clinical Data Management Services now offered In-House

  • Design and development of case report forms and source documents
  • eCRF completion and archiving
  • Double data entry
  • Data Management Plan
  • Safety Data Tabulation
  • MedDRA Coding
  • File Transfer

• LC-MS/MS Bioanalytical Services now offered In-House

  • Method feasibility
  • Method development
  • Method validation (GLP)
  • Method transfer
  • Bioanalysis of biological samples from BE/BA studies and Clinical PK Studies