Focus

PharmaLand Consulting Group (PLCG)  is focused on strategic statistical, scientific and regulatory consulting in metabolic disorders, genitourinary diseases, gastroenterology, respiratory and allergy, CNS, cardiology, dermatology, infectious diseases, and oncology, with a special focus on rare diseases including gene therapy. 

We advise on clinical development plans, study designs, and worldwide regulatory submissions.

We have been conducting clinical due diligence efforts with the emphasis of statistical data review and re-analysis. Our experience covers representing sponsors and investors' groups in assessing viability of clinical assets.

PLCG has experience with well over a dozen of rare disease indications, including dermatology, metabolic disorders, and kidney and liver disorders. Our experience includes gene therapy. 

PharmaLand Consulting Group provides statistical consulting starting with clinical development plans, through phase 1-4 clinical study design (study protocols, statistical analysis plans, clinical study reports, and briefing documents) to post-marketing commitments, claim support, and scientific publications. 

This includes group sequential and adaptive designs, categorical data analysis, longitudinal data analysis, multiplicity control, composite endpoints, and multivariate analysis. 

We participate on Data Safety and Monitoring Boards.

We advice on post-approval research including Real World Evidence, disease registries, observational studies, and retrospective data analysis.

PLCG  performs data re-analysis, and data mining to aid in redirecting development goals for failed trials  and drug re-purposing.

We advise in the area of Rx medicines, biologics, vaccines, medical devices, diagnostics, OTC medicines, Rx to OTC switches, medical food, and nutraceuticals. 

We have experience with worldwide submissions including Japan.  

Strategic regulatory consulting covers advice on submissions contents, including gap analysis of existing data packages, preparation of integrated submission documents, response to international regulatory queries, advice on regulatory issues including participation in FDA meetings, and Advisory Committee meetings preparations.

PLCG can help to evaluate CRO capabilities, review proposals to aid sponsor's decision making on CRO selection. We can provide oversight during clinical study activities and during preparations of regulatory submissions.