EARLY STAGE CLINICAL DEVELOPMENT SERVICES

EARLY STAGE CLINICAL DEVELOPMENT

We at ClinSync, have a strong expertise to design, develop and execute early development programs that allow clients to make right decisions, increase efficiencies and reduce timelines.

We have a strong clinical expertise and strategy at an early phase stage which is critical to long-term clinical success. As a full service early stage CRO that is not only capable of providing the clinical conduct of your studies, but had the ability to provide all round end to end services which ensures right evidence is collected to help you move to the next step.

 

Our Broad Spectrum of Early Stage Developmental Programs Include:

First-in-Man Programs (SAD + MAD (NBE Indian client) + FE + CYP450 Interaction)

Microdosing studies

Clinical PK/PD studies

Imaging (PET, fMRI) studies

Bioavailability/ANDA studies

Bioequivalence/ANDA studies

Vaccine studies

Cardiac Safety/Thorough QT/QTc studies

Drug-Drug Interaction studies 

PK bridging studies for Market Formulation Vs Final Market Image Formulation Vs Clinical Trial Formulation- Rectal foam studies, Fecal Biomarker study, Renin-angiotensin biomarker study, Pharmacoscintigraphic Imaging, Intramuscular or sub-cutaneous injection studies.

 

Our Early Stage Developmental Services Include:

Review of Preclinical Data

Design and Preparation of the Trial

Clinical Project Management

Preparation of the Study Protocol, Informed Consent, and Case Report Forms

Clinical Conduct

Clinical Data Management

Biostatistics

Bioanalysis

Conduct PK/PD and/or Pop PK/PD Data Analysis and Modeling

Prepare PK/PD Report

Prepare and publish Fully Integrated Clinical Study Reports

Monitoring

Safety Monitoring