Services
Princeton Pharmatech provides professional quality deliverables in a timely manner while maintaining the highest level of scientific integrity.
Choice of primary and secondary endpoints
Clinical Trial Statistical Planning
We excel in the statistical design of pivotal Phase 2 and Phase 3 clinical trials in oncology, neurology, and rare disease.
Instead of treating clinical trial design as a mathematical problem fitting to all disease areas, we start with a deep understanding of the disease, the compound, and the competitive environment. We strive to be the true partner of your clinical scientists, designing the study with a focus on the quantitative assessment and empirical side of each study design.
We work with clinical stage companies on pivotal Phase 2 proof-of-concept studies with a focus on how these studies can de-risk the entire clinical development program. We effectively balance completeness of data collection and the need to get sufficient data for the go/no-go decision of the entire clinical program.
Our pivotal Phase 3 study designs are about the margin of safety needed to ensure that a good drug does not fail due to the improper design. To improve the margin of safety within a reasonable cost, we leverage a biomarker-based enrichment strategy to understand the study population in complex heterogeneous diseases, apply state-of-art adaptative study design for early discontinuation or sample size re-estimation, and apply advanced analysis methods of covariance adjustment and missing data to reduce the endpoint variance.
Clinical Trial Protocol Development
Our work focuses on quantitative study design and includes:
Statistical Analysis Plan
Analysis plans for clinical trials are designed to answer key questions at each development stage. Our statistical analysis plans include:
Adaptive Study Design
We work with our partner experts in Bayesian-based adaptive design and frequent based adaptative design. These studies include interim futility stop, interim stop for efficacy, and blinded/unblinded sample size re-estimation.
Advanced Statistical Model Development
We are able to rapidly implement state-of-art analysis for FDA submission. These advanced models can significantly impact the regulatory approval process. These models include:
Case studies for enrichment strategy to understand study population in the complex inhomogeneous diseases, adjusting for treatment switching in oncology trials, and Bayesian subgroup analysis with hierarchical models
Clinical Trial Implementation
In addition to high-level statistical study planning, we work with you and your CRO to implement data integration, data surveillance review, statistical analysis, and data regulatory submission for a successful clinical trial implementation.
Our experience in implementing study analyses from phase 1, phase 2, phase 3, health authority submissions, and post-submission marketing allow us to foresee any final stage analytical issues early in the clinical trial implementation. Our data integration, data standardization, and data surveillance, along with final data analysis ensures that possible data gaps are addressed early during the clinical trial. This helps to avoid data inconsistencies, missing data, early dropout, and incorrect data collection for key endpoints.
All data analyses are 100% compliant with FDA quality regulation and FDA data submission standards and our statisticians and SAS programmers all have multiple successful NDA/BLA submission experience. Our process and systems are routinely audited by sponsor companies for compliance to standard operation procedures and FDA quality regulation. Our data standard experts are active members of the CDISC working group and Princeton is a member of CDICS.
List of our FDA/EMEA submission experience.
We understand the therapeutic area, your development program, your study design, and the specific analysis goal at every development stage. Our analyses strive to have high impact to your bottom-line directly. We serve all of your data analysis needs. After a high-level discussion we will take care of all of the analysis details.
Clinical Trial Data Integration (Initial)
A larger volume and more types of data are collected in today’s clinical trials. To ensure proper capture, we create a hub for all your clinical trial data which includes CRF, central lab, biomarker, genetic, central reading center, PK and other research data. We can help establish a data transfer agreement with each data source, reconcile between the different data sources and standardize the data into a CDISC format.
Clinical Trial Data Review (Ongoing)
As the clinical trial becomes decentralized in operation, real-time statistical risk-based data quality surveillance becomes more important for early discovery of data collection issues to improve quality. Continuous review of key primary and secondary efficacy and safety endpoints with detailed collected data in the graphic form will help the medical research scientists to better understand the clinical trial progression.
Clinical Trial Data Analysis (Final Stage)
Our expert statisticians have extensive experience conducting analyses for different stages of clinical development. The analyses can be conducted in clinical trial design, interim implementation, final primary analyses, and post-lock additional analyses. We tailor our analyses for the different purposes of analysis and different stages of the clinical trials. We have the track record to conduct complex analyses in a short timeline.
Clinical Trial Data Regulatory eSubmission
Our specialty is 100% compliance with FDA regulation for data standards, analysis methods, and quality compliance. Our statisticians and SAS programmers are experts in producing data deliverables to submit to FDA, EMEA, and other regulatory agencies. We stand behind our deliverables to answer regulatory questions or conduct additional analyses based on inquiries from the health authorities in an accelerated timeline.
Post Approval Analysis
Our extensive working knowledge of clinical trials data and analyses used to support regulatory approval translates to rapid scale-up of the analysis operation for medical affairs and market access purposes. We pioneered real word data analyses to combine the clinical trial data, insurance claim data, and electronic medical records for the neurology medicines.