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Phase I clinical trials, BE/BA study, general PK/PD

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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Phase 1 Clinical Pharmacology Study

Clinical Trials >> Early Clinical / Phase I-IIa >> Phase I / IIa

Quotient has the experience and expertise to deliver studies with the highest quality service and speed to clinical data. If you need a complete service including data management, data analysis, statistics and medical writing, Quotient is your answer.

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Rapid Subject Recruitment

Clinical Trials >> Patient / Investigator Recruitment >> Patient Recruitment

Quotient has the experience and expertise to deliver studies with the highest quality service and speed to clinical data. If you need a complete service including data management, data analysis, statistics and medical writing, Quotient is your answer.

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High-Quality Regulatory Submissions

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

Quotient has an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the U.S., ensuring the production of high-quality dossiers and a seamless submission and approval process for Phase I clinical trial application.

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In Silico Modeling & Simulation

Clinical Trials >> Compliance, Regulatory & Consulting >> Clinical Trial Design

We provide in silico modeling and simulation for all our formulation design and selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical and pharmacokinetic data, providing valuable insight into the in vivo performance.

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Data Management & Database Programming

Clinical Trials >> Technology / Data / Analytics >> Data Management

Study database set-up and maintenance, Data Management Plan, data cleaning, coding, query issue and database lock.

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Statistics & Statistical Programming

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Protocol input, sample size calculation and randomization, Statistical Analysis Plan and formal statistical analysis/interpretation, Program/QC study listings, tables and figures using SAS, Program/QC CDISC datasets (SDTM and ADaM) using SAS, Define.xml.

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Pharmacokinetic Analysis Using Phoenix WinNonlin

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Rapid interim PK turnaround times for formulation decisions or SAD/MAD safety evaluation, Modeling and simulation using GastroPlus, including development of IVIVCs

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Medical Writing

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Clinical study report according to FDA guidance for industry and related submissions using eCTD specification.

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Rapid Data Delivery

Clinical Trials >> Technology / Data / Analytics >> Data Management

You need your data rapidly to make crucial dosing decisions during a study. At Quotient, data are available in the study database within hours of collection, ready for remote sponsor access.

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