VOICES

Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

VOICES

Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.

All

Knowledge Base

News

Therapy Areas

Glossary

FAQ

Guidance Docs

21 CFR Part 11

510(k)

510(k) Clearance

ADaM (Analysis Data Model)

Adaptive Design

Adaptive Enrichment Design

Adverse Event

Advisory Committee (Panel Meeting)

Alpha-Spending Function

Annotated CRF

Approvable Letter

Audit Trail

Bayesian Methods

Benefit-Risk Assessment

Blinded Assessment

Blinding/Masking

Breakthrough Device Designation

CE Marking

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

Center for Drug Evaluation and Research (CDER)

Clinical Data Interchange Standards Consortium

Clinical Events Committee

Clinical Study Report

Co-Primary Endpoints

Competing Risks Analysis

Complete Response Letter

Composite Endpoint

Conditional Power

Confidence Interval

Core Lab

Core Lab Assessment

Crossover Design

Data Safety Monitoring Board/Data Monitoring Committee

Data Specifications

Database Lock

De Novo

Define.xml

Device Deficiency

Early Treatment Diabetic Retinopathy Study

Effect Size

Efficacy Endpoints

Electronic Case Report Form

Electronic Common Technical Document

Electronic Data Capture

Enrollment/Accrual

Equivalence Design

European Medicines Agency

Exploratory Endpoint

FDA Guidance Document

FDA Pre-Submission

Feasibility Study

First-in-Human Study

Follow-up

Frequentist Methods

Full Analysis Set

Futility Analysis

Good Clinical Practice

Good Laboratory Practice

Good Manufacturing Practice

Health Canada

Hierarchical (Mixed-Effects) Model

Historical Controls

Humanitarian Device Exemption

ICH E3

ICH E6

ICH E9

ICH E9(R1)

Informative Prior

Informed Consent Form

Institutional Review Board/Ethics Committee

Integrated Summary of Effectiveness

Integrated Summary of Safety

Intent-to-Treat Analysis Set

Intercurrent Event

Interim Analysis

International Council for Harmonisation

Investigational Device Exemption

Investigator's Brochure

Last Observation Carried Forward

Lost to Follow-up

Major Adverse Cardiac Events

Medical Dictionary for Regulatory Activities

Meta-Analysis

Methodological Innovation

Minimum Clinically Important Difference

Missing at Random

Missing Completely at Random (MCAR)

Missing Data

Missing Not at Random

Modified Intent-to-Treat Analysis Set

Multiple Imputation

National Health Commission of the People’s Republic of China

National Medical Products Administration

Neck Disability Index

Non-Inferiority Design

Non-Informative (Vague) Prior

Notified Body

Null Hypothesis

Observer-Reported Outcomes (ObsROs)

Oswestry Disability Index

p-value

Panel Preparation

Parallel Design

Patient-Reported Outcomes

Pattern-Mixture Models

Per-Protocol Analysis Set

Performance Goal (Objective Performance Criterion)

Performance Outcomes

Pharmaceuticals and Medical Devices Agency

Pivotal Trial

Platform Trial

Post-Market Study

Posterior Probability of Success

Pre-Sub Package

Preferred Term

Premarket Approval

Primary Endpoint

Principal Stratification

Propensity Score Methods

Protocol

Protocol Amendment

Protocol Deviation

Radiographic Success

Random Effects

Randomized Controlled Trial

Registry Trial

Regulatory Biostatistics

Rescue Therapy

Response Evaluation Criteria in Solid Tumors

Response-Adaptive Randomization

Safety Endpoints

Sample Size

Sample Size Re-estimation

Seamless Phase II/III Design

Secondary Endpoint

Sensitivity Analysis

Serious Adverse Event

SF-36

Sham Control

Single-Arm Study

Standard Operating Procedures

Statistical Analysis Plan

Statistical Power

Steering Committee

Stopping Rules

Study Data Tabulation Model

Submission-Grade Analysis

Summary of Safety and Effectiveness Data

Superiority Design

Surrogate Endpoint

Synthetic Control Arm

System Organ Class

Tables, Listings, and Figures

Time-in-Range

Tipping Point Analysis

Type A Meeting

Type B Meeting

Type C Meeting

Type I Error (Alpha)

Type II Error (Beta)

Unanticipated Adverse Device Effect

Validated Environment

Validation

Version Control

Visual Analog Scale

Weakly Informative Prior

WOMAC

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BSC®

Get regulatory insights

that help you work smarter.

Receive updates on clinical trial methodology, regulatory developments, FDA guidance, and practical biostatistical insights drawn from real-world experience.

By proceeding, you agree to our Privacy Policy

BSC®

Get regulatory insights

that help you work smarter.

Receive updates on clinical trial methodology, regulatory developments, FDA guidance, and practical biostatistical insights drawn from real-world experience.

By proceeding, you agree to our Privacy Policy

BSC®

Get regulatory insights

that help you work smarter.

Receive updates on clinical trial methodology, regulatory developments, FDA guidance, and practical biostatistical insights drawn from real-world experience.

By proceeding, you agree to our Privacy Policy

Questions answered

Any other question?

Let's help you find a path

to market

  • About BSC®

    Working With BSC®

    Services

    Project logistics

    Data and Software

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to market

  • About BSC®

    Working With BSC®

    Services

    Project logistics

    Data and Software

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to market

  • About BSC®

    Working With BSC®

    Services

    Project logistics

    Data and Software

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Questions answered

Any other question?

Let's help you find a path

to market

  • About BSC®

    Working With BSC®

    Services

    Project logistics

    Data and Software

  • What does BSC specialize in?

    What types of clients do you work with?

    What therapeutic areas do you cover?

    How is BSC different from a CRO?

    What size projects do you handle?

Biomedical Statistical Consulting®
Biomedical Statistical Consulting®
Biomedical Statistical Consulting®
Biomedical Statistical Consulting®

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.

Request Expert Review

Backed by Regulatory Experience.

Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.

Confidential discussion with senior biostatisticians experienced in FDA submissions.