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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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Device Studies

Clinical Trials >> Compliance, Regulatory & Consulting >> Medical Devices

Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.

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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.

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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

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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.

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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.

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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.

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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.

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Clinical Development Services & Solutions

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase II / III

Chiltern provides the following services for Phase lllb - IV Post-marketing Late-stage programs: Post-approval GCP studies, Disease, product and pregnancy registries, Epidemiological studies, Restricted access and compassionate use programs, Retrospective and chart extraction studies, Risk

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