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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.

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.

Pharmacovigilance & Safety Reporting

Clinical Trials >> Post Marketing >> Pharmacovigilance / Product Lifecycle Management

We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.

BioVisualization

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

Our BioVisualization service is designed to query our clinical sample databases in real-time, so your most current data is being examined. The figures are downloadable for ease of sharing with colleagues and incorporation into reporting documents.

Clinical Development Strategy

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

DZS Clinical Services provides expert consultation and advice on the strategic direction of your clinical trial for your drug product or device across many therapeutic areas in the biopharmaceutical, medical device and government and nonprofit sectors.

Product Development Consulting

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

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

AxxiTRIALS

Clinical Trials >> Technology / Data / Analytics >> Clinical Trial Monitoring

AxxiTRIALS is a fully automated, unified eTMF and site investigator portal that allows regulatory document exchange between clinical trial sites and sponsors.

Strategic Regulatory Services

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

Our regulatory consulting team serves clients around the globe from biotech startups to big pharma as well as the research, investment, and legal firms that serve them.

Clinical Evaluation Report (CER)

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

Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources.

Clinical Trial Management System (CTMS) Software

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

A Clinical Trial Management System (CTMS) is a software solution targeted for the Life Science industry. CTMS is commonly used to manage processes and large amounts of data involved with clinical trial management and clinical study management.

PharmaCompass