Data-Driven Insights for Smarter Clinical Decisions
BiostatisticsEarly statistical input is essential for designing reliable and efficient trials. Our experts help optimize study design, sample size, and data analysis methods to enhance trial credibility and regulatory approval.
Ensuring scientifically rigorous trial designs from the outset.
Maximizing statistical power while optimizing resources.
Enhancing flexibility and efficiency in clinical research.
Implementing unbiased methods for reliable study outcomes.
Supporting data-driven decision-making during trials.
Choosing the right randomization approach is crucial for trial success. Bioforum provides tailored solutions, including dynamic randomization, stratified allocation, and multi-stage designs, to align with your study goals.
Ensuring patient safety and data integrity is paramount. Our Data Monitoring Committee (DMC) services support independent expert review to safeguard trial success.
Providing unbiased analysis and reporting.
Reviewing roles, responsibilities, protocols and delivery requirements.
Supporting timely decision-making.
Maintaining compliance and data security.
Delivering precise statistical insights.
Leveraging adaptive designs and advanced randomization.
Bioforum offers end-to-end biostatistical and statistical programming services. This includes assistance with study design, writing the Statistical Analysis Plan, receiving raw data from Data Management and other vendors, converting to standard and analysis data formats such as SDTM and ADaM, generating analysis outputs (Tables, Listings & Figures) and authoring the statistical section of the CSR. Bioforum can also help you with data conversion to other data standards, legacy study support, statistical analysis, data integrations (ISS\ISE), DMC\DSMB report and unblinded support and independent quality review.
As a mid-size CRO, we are big enough to cover all your biostatistics and statistical programming needs, and small enough to ensure that all our projects are being managed effectively, regardless of size or scope. With a customer base including pharma, academia and non-profit, CROs and EDC companies, the broad spectrum of clinical research sectors, combined with experience in a variety of therapeutic areas over all study phases, promotes skill development in all areas of statistical programming. Our innovative culture is showcased by the recent launch of our JetConvertTM technology, an SDTM conversion tool that uses machine learning with no SAS involved, resulting in significant reduction of effort required to produce SDTM datasets of superior quality.
Through our independent Quality Assurance (QA) department and quality management system, we ensure that both processes and deliverables meet the industry standards and customer requirements. We leverage internal processes like quarterly internal audits, periodic review of controlled documents, continuous training, individual development plans, continuous process improvement, timely and thorough action on deviations, audit findings, customer complaints and CAPAs to maintain our reputation for quality. We are also ISO 9001:2015 certified.
Bioforum has experience in many different therapeutic areas. These include (in descending order of experience): oncology, neurology, psychiatry, cardiology, orthopedics, dermatology, gastroenterology, ophthalmology, gynecology, and immunology. This list is not exhaustive—we listed here just the top 10, and there are many more in which we have experience.
