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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.

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.

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

Subcutaneous Models

Clinical Trials >> Core / Central Lab >> Clinical & Medical Imaging

At MI Bioresearch, we offer more than 450 syngeneic and human tumor xenograft models, including drug-resistant and specialty models, and we are continually validating new models.

Solid Organ Transplant Solutions

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

The OTTR CompleteOrgan solution simplifies data collection, patient tracking and data management. Our software includes liver, kidney, pancreas, heart, lung, intestine and islet cell transplant solutions.

Periodic Benefit-Risk Evaluation Reports (PBRER)

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

Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

ClinPlus® Data Management

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

ClinPlus Data Management (CPDM) software, our classic data management system designed to support paper-based studies, has helped clients manage clinical studies across multiple therapeutic areas and collect quality data while meeting strict timelines and budget constraints.

Regulatory Services 

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

We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

Global Regulatory Affairs Services

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

PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.