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Pharmacokinetics / Pharmacodynamics / Pharmacometrics

Phase I / IIa

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BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Celerion

Chiltern International Ltd

ICBio Clinical Research Pvt Ltd

MPI Research Inc

Nutrasource

PAREXEL International Corporation

Particle Sciences

Pharmaceutical Product Development, LLC

Quotient Sciences

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CANADA

INDIA

PORTUGAL

UNITED KINGDOM

UNITED STATES

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Phase 1 Clinical Pharmacology Study

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

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Radiolabeled ADME Studies

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In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded its ADME suite in Lincoln, Nebraska.

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14C ADME / Mass Balance

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Quotient has the experience and expertise to seamlessly deliver several studies involving Bioavailability, dose proportionality, absolute bioavailability, Bioequivalence, 14C ADME / Mass Balance, Thorough QT (TQT) / cardiac safety, Pharmacodynamics etc.

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Clinical Development Services & Solutions

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Chiltern provides the following services for Phase llb - III Late-stage programs: Protocol feasibility and design, CRF development, Recruitment, Data management, Medical writing, Biostatistics, Drug safety monitoring committees

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Supporting Drug Development at Phase III

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MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Early Development Clinical Research Services

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Program services offered by both clinics range from medical writing, clinical conduct and data management to monitoring, biostatistics and clinical pharmacology.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Supporting Drug Development at Phase I & II

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MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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14C-Radiolabeled Microtracer Studies

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Celerion’s clinic in Lincoln, Nebraska, is the only Phase I facility in North America with proven experience to release radiolabeled drug to regulatory standards that has been formulated on site for intravenous use in humans. This is required to perform assessments of absolute bioavailability

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Global CRO- Phase I & ll Studies

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With over 40 years of experience, more than 600 beds in North America and Europe, Celerion offers the largest global Phase I and II clinical operations networks in the industry.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Clinical PK/PD and Pharmacometrics Services

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PAREXEL’s global team of experienced clinical pharmacokineticists and pharmacometricians offer unsurpassed expertise in Clinical PK/PD and Pharmacometrics, from pre-clinical to Phase III studies.

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Bioequivalence Studies

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With more than 40 years of experience in performing bioequivalence studies, our clinical unit in Bloemfontein, South Africa, is a center of excellence. It is strategically placed in the perfect location for these trials a lower cost and fast start-up environment.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Early Phase Clinical Trials

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We have a speciality in early phase trials involving healthy volunteers. Early phase trials may have many factors that must be considered to achieve the research goals.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Phase I Clinic Capabilities

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PPD’s Phase I clinic conducts approximately 100 studies per year and has sufficient capacity to carry out multiple studies of varying design simultaneously. Research-experienced, board-certified physicians serve as principal investigators for Phase I studies. Secure and confidential drug

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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ADME / Mass Balance

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The ADME (Absorption, Distribution, Metabolism and Excretion) Suite includes new state-of-the-art equipment and laboratory space to perform on-site scintillation counting allowing for radioactivity recovery results to be delivered in real-time.

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Phase 1 Clinical Trials

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PAREXEL® has the global SOPs to perform Phase 1 clinical trials in harmony across multiple locations, and stands committed to the success of your journey.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Phase lla

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PAREXEL® has developed an integrated and adaptive approach that supports Phase IIa outcomes.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Study Start-Up

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Our team understands that upfront planning is critical for the success of every clinical trial and that planning must be produced in cooperation with your clinical team.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Phase 1 Clinical Pharmacology Study

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We have capabilities to conduct Phase I Studies on Healthy Volunteers & offers Phase I studies for NCEs & NBEs. We also offer services on clinical pharmacology studies including Food Effect, Drug Interaction studies, PK/PD studies, studies for biomarkers.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Phase I Studies

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Bluepharma performs its activity from product development to the end of the value chain, that is, finished product supply.

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Pharma Service: Clinical Trials

Category: Early Clinical / Phase I-IIa

Sub Category: Phase I / IIa

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Pharmacokinetic Services

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Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing. For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, Particle Sciences has the solution.

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