Biometrics CRO Services

Delivering advanced data-based insights to support evidence-based decision-making

OUR TEAM’S EXPERTISE

Our clients cite the following reasons for choosing our biometrics CRO services:

We have doctorates in statistics from leading universities, such as Harvard, Stanford, and Columbia.
We include renowned scholars and talented professors with extensive backgrounds in statistics and biostatistics.
We have over 100 years of technical experience. Additionally, we are experts in statistical analysis (e.g., t-test, ANOVA, ANCOVA, traditional regression, logistic regression, MANOVA, MANCOVA, factor analysis, cluster analysis, survival analysis, time series analysis, correlation analysis, meta-analysis, and more advanced statistical techniques such as structural equation modeling (SEM), hierarchical linear modeling (HLM), and path analysis).
Our analysts use various software packages, including SPSS, SAS, Stata, HLM, Mplus, R, SPSS Amos, SPSS Modeler, Azure, JMP, Python, WinBUGS, Minitab, SYSTAT, LISREL, EQS, Smart PLS, WarpPLS, EViews, and many others.
Our biostatistical consultants use the latest statistical software available today. In addition, they can apply the required technical and specialized techniques and procedures of statistics. Thus, we are confident you will be satisfied with our biostatistical consultants.
We are more reasonably priced than most other firms. Thus, our fees are pale compared to the savings our help generates for our clients.
We offer friendly support and ultra-fast turnaround times.
Over 90% of clients request our assistance more than once, as they are almost universally happy with our different brands.
We possess good communication skills. Therefore, we can interact with our clients fluently and comfortably.
We are members in good standing of the Statistical Consulting section of the American Statistical Association.
We are committed to quality and excellence, reflected in our record of five-star reviews.
Our diverse team of scientists brings a wealth of knowledge spanning pharmacology, physiology, therapeutics, and acute and chronic diseases, contributing to a comprehensive understanding of clinical research.
As a CDISC member, we prioritize compliance and can deliver SDTM and ADaM packages tailored for regulatory submissions across various therapeutic areas.

Statistical Services

Statistical input into study design & protocol development
Adaptive study designs
Sample size calculations
Analysis plans
Optimizing study success
Identifying the primary endpoint
Modeling and simulation
Prediction of drug exposure
Optimal evaluation of information for ongoing clinical trials
Independent data monitoring committees
Setting up randomisation schemes
Multiplicity (optimally evaluate more than one outcome in a trial)
Regulatory advice
Observational and epidemiological studies
Interpretation of results
Data visualization
Statistical training

Data Management

Cross-functional biometrics team plans
EDC, including accredited Medidata Rave support
Paper CRF and hybrid options
Risk-based monitoring
IWRS
CDASH standard datasets
Database build and validation
Data entry
Extensive edit checking
Clinical Team and Site training, mentoring, and support with EDC
Site metrics for CRF completion and Query Resolution
Continual Quality Control review, including audit trail logging
MedDRA and WHODrug coding
AMP, cell therapy studies, Observational, Device and Marketing studies
3rd party vendor oversight and data transfer planning

Data Science

Development of bespoke visualizations to support data interpretation and monitoring
Algorithm development and the use of machine learning to support precision medicine, e.g., predictive biomarkers
Maximizing the value of patient-generated data such as wearables and biosensors.
Application of machine learning and artificial intelligence techniques to maximize the value of clinical data and its metadata
Identification of data sources and associated analytics to answer critical questions
Development of data visualizations enabling teams to explore data independently
Analysis of historical and operational data, providing data insights and driving benefit
Integration & analysis of clinical data alongside Electronic Healthcare Records (EHRs), Real World Data (RWD) and other omics datasets

Medical Writing

Document Management for Protocols

Protocols & Amendments: Assistance from synopses to complete protocols and their crucial amendments.
Consent Forms to Reports: Comprehensive assistance with informed consent forms, safety narratives, clinical study reports, and more.
Regulatory Compliance Documents: Assistance with Patient information leaflets and annual safety reports.

Expertise in Regulatory Submission

Submission Documents: Specializing in IND, CTA, NDA/sNDA, MAA, NDS, and jNDA.
Comprehensive Summaries: Preparation of clinical and non-clinical summaries (Module 2) and integrated summaries of efficacy and safety (Module 5).
Reviewer Responses: Expert drafting of responses to agency reviewers, ensuring clarity and compliance.

Regulatory Meetings & Risk Management

Regulatory Briefings: Assistance with tailored documents for pre-IND, end of Phase 1/2/3, pre-NDA meetings, and more.
Risk Management Plans: Development of plans to mitigate risks, ensuring your submissions are comprehensive and compliant.

Functional Service Provision

Experienced Data Specialists
Vital Role in Biopharma Research
Growing Demand for Specialist Expertise
Global Clinical Data Solution
Expert Teams for Clinical Programs

Ready to advance your project to the next phase?