Cetero specializes in providing comprehensive scientific affairs services from initial study-design consultation to data management and biostatistics through to final-report submission.
Our scientific affairs services include:
Consistent study conduct – from study design to study execution, sample management, data delivery through to final report – all lead to the quality data you will receive.
Our strong scientific background and industry experience allow us to consult with you on study designs for virtually all therapeutic areas. In the past three years, our scientific affairs department has completed work for nearly 3,000 phase I-III projects.
Whether you require full scientific affairs or “à la carte” services, Cetero can accommodate your drug-development needs. Each of our core scientific affairs services can also be utilized separately and integrated with your clinical and bioanalytical partner of choice.
Cetero has a proven track record of delivering accurate data when you want it, in a format you want, with an unwavering commitment to quality.
Would you like more information on our scientific affairs services?
Scientific and Regulatory Affairs Services
- Specialist consultation for clinical drug development for generic, supergeneric and new drugs/biologics
- IND and CTA filing
- IB compilation and finalization
- Electronic common technical documents (eCTD)
- Participation as expert consultants in pre-CTA/pre-IND, end of phase I, and pre-NDA meetings
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Medical/Report Writing Services
- Protocol development and review
- Informed consent development and review
- ICH-compliant study reports, including SAS generated tables and listings
- Clinical study reports for FDA, Health Canada and EMEA
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PK/PD Services
- Selection of study endpoints and appropriate study designs
- All types of PK/PD analysis including global population PK/PD analyses and reporting
- Modeling and simulations
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Biostatistics Services
- Statistical analysis of BE and Phase I-IV studies
- Average and scaled BE approaches
- Statistical analysis plans
- Generate randomization schemes
- Create and validate SAS programs
- Generate Tables, Listings and Graphs
- Statistical reports
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Data Management Services
- Electronic case report forms
- Data management plan
- Database setup and validation
- Electronic data capture
- Query resolution
- Adverse events and medical coding
- CDISC
- CDASH
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Our core scientific and regulatory study experience includes:
- First-in-Human and pivotal Phase I:
- Single and multiple ascending dose in healthy participants or patients
- Proof-of-Concept / PK-PD
- Objective or subjective measures performed in-house or with patient diaries and linked to the PK of the drug for robust prediction or confirmation of safe and effective dosing regimens for your drug candidate before Phase II.
- Interaction
- Drug-drug, drug-food, and alcohol interaction
- Bioavailability
- Absolute bioavailability, bioequivalence
- Special populations
- age (e.g., adolescents, elderly), gender, special populations (e.g., poor metabolizers), renal or hepatically-impaired
- Modeling and simulations
- Learn and Confirm cycles of modeling and simulations from pre-clinical through Phase III
- Monte Carlo simulations
- Individual or Global population PK/PD analyses
- Robust dose-response multi dimensional analyses to confirm the minimum effective dosing regimen of your drug/biologic
- Thorough QT studies
- Expert at consulting, designing, performing and analyzing TQT
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