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| Bioequivalence Studies and Phase I/ IIa Clinical Trials |
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Bio Pharma Services Inc. provides a wide range of services under the management of highly trained and knowledgeable team of professionals. All studies are conducted in accordance with Good Clinical Practices, ICH, Federal Regulations and rigorous Standard Operating Procedures. |
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We offer |
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- Experienced research team of 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
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Services Overview |
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Protocol development and review |
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- 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
- Bridging studies
- Ascending dose studies
- QTc studies
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Clinical Execution of the Protocol |
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- Extensive database of healthy male and female volunteers, post-menopausal females
- Toronto site: 3 independent mixed-gender 48-bed units (144 beds) capable of short term & long term confinement, plus a 14-bed First-in-Man Phase I/IIA clinic.
- Karachi site: 3 independent mixed-gender 40-bed units (120 beds) capable of short term & long term confinement
- Experienced physicians, nurses, phlebotomists and
technicians dedicated to subject safety and data integrity
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Clinical Data Management |
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- Document development and design of case report forms
- Project management and monitoring
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Partner with bioanalytical laboratory |
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- Method development, validation and transfer
- High throughput analysis of biological specimens
- Electronic data transfer and interim reporting
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Pharmacokinetic/Pharmacodynamic analysis and statistical
analysis |
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- Analysis and interpretation of analytical and statistical
data
- Pharmacokinetic modeling
- Population pharmacokinetics
- Analysis of clinical endpoints
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Integrated Report Writing and Electronic Submissions
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- Compliant with ICH, and requirements of USA, EMA, TPD and other regulatory agencies as required
- CTD format reports
- eCTD
- Post-submission regulatory follow-up
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Quality Assurance auditing with independent
reporting to Management |
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