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Bioavailability / Bioequivalence

Pharmacokinetics / Pharmacodynamics / Pharmacometrics

Phase II / III

Phase IV

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Celerion

Chiltern International Ltd

Dalmia

Evidera

Greenleaf Health Inc

ICBio Clinical Research Pvt Ltd

MPI Research Inc

Navitas Inc

Nutrasource

PAREXEL International Corporation

Pharmaceutical Product Development, LLC

QUINTA-ANALYTICA s.r.o

Quotient Sciences

Reliance Clinical Testing Services, Inc

Spaulding Clinical, LLC

TFS International AB

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CZECH REPUBLIC

INDIA

SWEDEN

UNITED KINGDOM

UNITED STATES

Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Phase I Clinical Trials & BE/BA Study

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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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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Bioavailability & Dose Proportionality

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Quotient has the experience and expertise to seamlessly deliver several studies involving bioavailability, dose proportionality, absolute bioavailability, bioequivalence, food effect, thorough QT (TQT) / cardiac safety, biosimilars, pharmacodynamics etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Clinical Development Services & Solutions

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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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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Human Repeat Insult Patch Test (HRIPT)

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To determine the safety of topical products, RCTS provides a range of clinical testing procedures, including a broad range of in-use and patch studies. Human repeat insult patch tests (HRIPT) for contact sensitization/irritation and acute or cumulative patch tests irritation.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Premarket Preparation

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Greenleaf Health Inc. offers various services such as: Combination product designations; Requests for device classification (513(g)); Presubmission strategy; Identification of predicate devices; Determination of and compliance with performance data and labeling requirements; etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Bioavailability / Bioequivalence Studies

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Quotient has the experience and expertise to seamlessly deliver several studies involving bioavailability, dose proportionality, absolute bioavailability, bioequivalence, food effect, thorough QT (TQT) / cardiac safety, biosimilars, pharmacodynamics etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Premarket Submissions

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Greenleaf Health Inc. offers various services such as: 510(k) premarket notifications; Premarket approval applications (PMAs); Requests for de novo review of automatic Class III classification; Humanitarian use designation (HUD) / humanitarian device exemption (HDE) applications; etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Clinical Development Services & Solutions

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Chiltern provides the following services for Phase I - lla Patient Studies early stage programs: Protocol feasibility and design, CRF development, Recruitment, Data management, Bioanalytical, Biostatistics

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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PK / PD Modelling & Simulation

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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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Marketing & Promotional Practices

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Greenleaf Health Inc. offers various services such as: Strategic guidance on labeling requirements; Promotional materials; Direct-to-consumer advertising review processnRemediation of untitled and warning letters; Use of social media.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Interventional Studies

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Evidera’s interventional study team has extensive experience in designing global, regional and single country studies in the peri- and post-approval space, including traditional IIIb/IV studies as well as Extended Access/Open Label Extension, Expanded Access/Compassionate Use, etc.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Claims Substantiation & Efficacy Testing

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Claims substantiation plays a key role in a product’s success and helps ensure the product stands out against competitors. From moisturization and barrier function, to anti-aging and color changes, rely on RCTS for your product claims substantiation and efficacy testing needs.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Pharmacokinetics / Pharmacodynamics (PK/PD)

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Celerion’s team of clinical pharmacologists has extensive expertise in PK/PD data assessment and consults with clients on the appropriate analytical approach for clinical studies.

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Supporting Drug Development at Phase IV

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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: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Generic Drugs / Biosimilars

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Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Non-compartmental PK & PD Analysis

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Toxicokinetic Analysis & Bioanalytical Data R...

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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PK Reports

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Population PK Analysis

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Biosimilars

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Celerion leverages more than 30 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Phase II & Phase III Clinical Trials

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At Nutrasource, we combine clinical expertise in the areas of nutrition, nutraceuticals and pharmaceuticals, as appropriate, to manage trials efficiently and effectively to support product investigations in support of a successful product launch.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Clinical Development Services

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Our experience, support systems and infrastructure enable us to provide the highest level of program management and clinical development services for Phase II-IIIb clinical trials.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Phase IV Monitored Trials

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Phase IV monitored trials collect data to address issues that support product success in a real-world clinical practice. With our extensive Phase IIIb-IV experience, PPD designs and executes Phase IV monitored trials.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Phase ll-lll

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Your progress to Phases IIb and III will have twists and turns. PAREXEL’s worldwide infrastructure and end-to-end expertise can help you optimize your studies and implement pivotal trials expeditiously.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Phase lllb-lV

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PAREXEL® has provided world class Late Phase services for over a decade. This is why we know this part of your journey so well. We helped plan it.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Bioavailability / Bioequivalence Studies

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We deliver the Bioavailability/ Bioequivalence study projects with high quality standards as per the set regulatory guidelines to ensure the efficacy and safety of each pharmaceutical products.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Bioavailability & Bioequivalence Studies

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BA/BE Studies are conducted at ICBio are in strict Compliance with International regulatory requirements monitored by QA department. We have considerable experience in conducting BA/BE studies on healthy & patient population with various dosage forms.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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PK / PD Patient Studies

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We offer services to conduct Pharmacokinetic and Pharmacodynamic studies / clinical endpoint studies on healthy volunteers and patient population to assist our clients with their drug development programs.

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Bioavailability & Bioequivalence Studies

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With a highly qualified and experienced team in place, Navitas can deliver even complicated studies with high quality outputs.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Phase II & Phase III Clinical Trials

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We provide end to end services on clinical trial: Early Phase Trials – Phase I & Phase II, Late Phase Trials - Phase III & Phase IV. We are providing solutions for Early & Late Phases trials with our hospital network across India & abroad.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase II / III

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Phase IV Clinical Trial

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We provide end to end services on clinical trial: Early Phase Trials – Phase I & Phase II, Late Phase Trials - Phase III & Phase IV. We are providing solutions for Early & Late Phases trials with our hospital network across India & abroad.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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Biologics & Biosimilars Studies

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Navitas' experience across innovator pharma and biologic Phase III studies, and pharmacokinetic studies enables us to partner with you to meet accelerated submission timelines while optimizing trial costs and regulatory risk of non-compliance.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Bioavailability / Bioequivalence

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Phase II - phase IV clinical trials

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Clinical trials are integral part of Drug Development. ICBio CRO offers end-to-end services for Phase II to IV clinical trials on small molecules, large molecules and medical devices with fully ICH GCP compliant operations.

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Pharma Service: Clinical Trials

Category: Clinical Development / Phase IIb-IV

Sub Category: Phase IV

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