Strategic Development

 

Our group of experts can help you set up and implement a development plan, focusing on the mechanism of action and pharmacokinetics of the drug or biotechnology compound being developed. Our knowledge spans a wide range of therapeutic areas:

 

Oncology

Cardiovascular (especially QT issues)

Gastrointestinal

Central Nervous System (psychiatry & neurology)

Endocrine (diabetes & obesity)

Pain (opiates & opiate antagonists)

Antifungals

Antivirals (HIV and hepatitis)

Immunology & transplantation

Biotechnology compounds

 

Nonclinical Consulting

 

We can help you set your strategy for:

 

Targeted drug development plans specific to therapeutic indication

Drug development implementation

The right group of experiments for non-clinical programs -pharmacology, toxicology, non-clinical PK/metabolism /ADME

Determination of optimum bio-analytical development

Regulatory submission -domestic and international

 

Clinical Consulting

 

With our expertise, we can help you design and manage:

 

First-time-in-man studies

Safety

PK/PD

TQT/cardiac safety

PK/Efficacy

Phase I clinical programs

Absolute bioavailability

Relative bioavailability

Food interaction

Special populations

Gender studies

Renal impairment or hepatic impairment

Elderly or pediatric

Drug/drug interaction studies

Radiolabeled metabolism trials

Proof-of-Concept trials

Biopharmaceutics program (bioequivalence, bioavailability studies) linked to CMC development

Phase II dose-ranging programs

n-licensing & Out-licensing strategies

Due-diligence review

Regulatory submission strategies -domestic and international

 

Data and Project Management

 

Data management and data base development

Validated EDC & paper database development (21 CFR subpart 11 compliant)

 

Clinical Trial Management for Clinical Pharmacology and Phase I/IIa trials including:

 

First-time-in-man studies

Special patient populations

Proof-of-concept trials

Pediatric and elderly trials

Cardiac safety (TQT) trials

Impaired populations (renal, hepatic)

 

Nonclinical PK/PD Analysis

 

Toxicokinetic analysis

Nonclinical PK/ADME analysis

 

Analysis

 

PK analyses and modeling

PK/PD modeling and analyses

Simulations

Receptor binding modeling

Population PK modeling and analyses

Statistical mixed effect models

Full range of statistical analyses

Final report writing with QA/QC

 

Back to Top