FAQ | BSC®

Q: What does BSC specialize in

[BSC® Specializes in regualtory biostatistics for sponsors in the medical device and life sciences industries. With nearly four decades of FDA expereince, we provide statistical leadership across trial design, analysis, and reporting. We support sponsors in preparing the statistical components of FDA submissions and regulatory interactions. We're particularly strong in complex progams where strategic statistical thinking and acvanced, regulatory-aware methods make the difference.

What size projects do you handle?

We support programs of many sizes — from discrete statistical deliverables and regulatory briefing packages (e.g., an FDA Pre-Submission) to multi-year support across late-stage and pivotal trial programs. Fit depends less on project length and complexity: if you’re facing challenging trial design questions, novel endpoints, or evidence-generation needs tied to evolving regulatory strategies, that’s where we add the most value.

What does BSC® specialize in?

BSC® specializes in regulatory biostatistics for sponsors in the medical device and life sciences industries. With nearly four decades of FDA experience, we provide statistical leadership across trial design, analysis, and reporting. We support sponsors in preparing the statistical components of FDA submissions and regulatory interactions. We’re particularly strong in complex programs where strategic statistical thinking and advanced, regulatory-aware methods make the difference.

What geographic areas do you serve?

We're based in the Philadelphia area and work with clients across the United States as well as internationally. We have extensive experience with regulatory submissions to US FDA, EU Notified Bodies, and many other global regulatory agencies. Most of our collaborations happens via video conferencing and email, with secure, access-controlled file sharing.

What therapeutic areas do you cover?

We support clinical development and evidence-generation programs, with extensive experience in medical devices — especially orthopedics & spine, cardiovascular, diagnostics and laboratory medicine (including IVDs), neurology, pain management, women’s health (OB/GYN-focused) devices, and diabetes/endocrinology devices. While our primary focus is medical devices, we also support select pharmaceutical programs, particularly studies using adaptive designs, Bayesian methods, or programs with complex regulatory considerations.

What are your team's credentials?

Our team includes MS- and PhD-trained biostatisticians with deep experience in clinical development and regulatory submissions. Across the group, we bring hundreds of years of regulatory biostatistics experience and have contributed to over 800+ projects spanning 510(k), De Novo, PMA/IDE, and select drug/biologic programs. Team members have authored hundreds of peer-reviewed publications and presented at professional scientific and industry conferences. Many of our statisticians have worked with BSC® for years, with senior statisticians with the company for over a decade. Collectively, our statisticians provide unparalleled institutional knowledge.

What types of clients do you work with?

We work with medical device and broader life sciences organizations—ranging from venture-backed startups preparing first-in-human/early feasibility work to established companies with extensive product portfolios. We support biotech, diagnostics/IVD, digital health/SaMD, and combination products. Clients engage us when they need regulatory statistical leadership expertise and a strategic partner for high-stakes or complex programs.

Can we engage you for urgent projects?

Yes. Our clients are engaged in high-stakes work where the FDA runs the clock. We have a proven track record of delivering results for clients even when engaged in the final days before an FDA response deadline.

Do you work with our existing CRO?

We regularly collaborate with other CROs and vendors. Depending on your workflow, we can lead or support statistical strategy, SAP/analysis planning, and reporting, while coordinating closely with your CRO (or in-house teams) on data management, operational oversight, regulatory submissions, and required interfaces.

How do we get started?

Reach out through the contact form on this site or email us directly. We'll set up a brief introductory call to learn about your program, understand your challenges, and determine whether BSC® is the right fit. There's no cost or commitment required for an initial conversation with our team.

Our timeline is extremely aggressive.

We've successfully delivered on compressed timelines and understand the urgency that regulatory deadlines create. Timing is always a concern for all of our clients. We will never respond “give us 6 weeks and here are 6 different project managers that will handle your study.” We won't compromise regulatory compliance or required quality. We'll be transparent about tradeoffs and we commit only to dates we can substantiate. We keep things on track through clear accountability: named decision-makers, agreed turnaround times, and timely access to the right stakeholders and materials.

Who will work on our project?

You'll be assigned a dedicated lead biostatistician as your primary point of contact, with senior statistician oversight of key deliverables, including analysis plans, critical outputs, and interpretation. For projects requiring FDA-facing experience, every FDA-facing engagement will be staffed with team members who bring direct, relevant regulatory experience.

Are you experienced with international submissions?

We routinely supported Sponsors with EMA, MDR, Health Canada, and CE mark submissions, as well as agency interactions. Our typical engagement includes work on the clinical/study design and writing deliverables (e.g., protocols, clinical/regulatory documents) aligned to ICH and relevant regional guidance. For programs targeting multiple regions, we can help shape evidence-generation plans to accommodate key regional expectations where feasible, and we generally recommend early scientific advice/agency feedback to confirm alignment rather than assuming one approach will be accepted by all authorities.

Do you have therapeutic area specialists?

Yes. Our statisticians have significant experience supporting medical device programs across multiple clinical areas (e.g., orthopedics and cardiovascular) and device categories (including diagnostics). We assign a lead statistician with relevant domain experience for your project and tailor the analysis approach to the applicable standards and submission requirements for your submission.

We've already worked with another statistician who said our study won't work.

An independent second review can be especially valuable when feasibility concerns have already been raised. We'll review any prior feedback (to the extent you can share it) alongside your study materials and assess whether the current design can support defensible inference under clearly stated assumptions. If the current plan isn't scientifically viable, we'll say so. The key is to focus on the highest-impact changes that could make it workable. Our goal is rigor and transparency, not forcing a result. You'll leave with either a credible path forward or a clear recommendation not to proceed with the current approach.

Do you support Bayesian methods?

Absolutely. We support Bayesian trial design and analysis and are experienced in prior elicitation, operating-characteristic simulations, decision-criteria selection, and sensitivity/robustness analyses. We help teams clearly document the rationale and statistical evidence (e.g., simulation results and error-rate considerations where relevant) so the approach is transparent, fit-for-purpose, and ready for regulatory review.

Can you help with complex endpoint design?

Yes — we frequently support complex endpoint design, including composite endpoints, time-to-event analyses, patient-reported outcomes, surrogate endpoints, and novel assessment approaches, tailored to the phase, indication, and data feasibility. We help translate clinical objectives into statistically sound, operationally executable endpoints, covering composite construction rules, endpoint hierarchy and multiplicity strategy, estimands and intercurrent events, adjudication considerations, and missing-data handling. We also support the development of endpoint justification packages including strategy memos, estimand frameworks, and SAP/briefing materials tailored for regulatory bodies and key stakeholders.

Can you help us design an adaptive trial?

Yes—adaptive designs are one of our core capabilities. We’ve supported approaches such as sample size re-estimation, seamless phase transitions, Bayesian adaptive methods, and response‑adaptive randomization. We work with you to define pre‑specified adaptation rules and decision criteria, and we run extensive simulations to assess and optimize the operational characteristics of your study. We also help develop the statistical documentation (simulation report inputs, SAP language) and the governance/operational plan (DMC/firewalls, data flow, and timeliness needs), and we support preparation of regulatory briefing materials and sponsor interactions in collaboration with your clinical and regulatory partners.

What if our trial doesn't have a control group?

Single-arm trials are common in device development, but FDA will still expect a credible way to interpret results. We help sponsors build rigorous, prespecified comparison frameworks using approaches such as performance goals (objective benchmarks), external or historical controls, and propensity score methods when patient-level external data are available. The right approach depends on endpoint objectivity, expected effect size, bias risk, and data provenance — and we recommend early FDA engagement (Pre-Sub/Q-Sub) to align on acceptability before you lock the protocol. We've supported sponsors through FDA interactions and submissions using each of these approaches, and we focus on making the comparison interpretable and defensible.

We're not sure what statistical support we need.

Totally understandable. Many teams aren’t sure what statistical support they need until we map your goals to the data you have. Let's discuss. Our clients come to us for everything from initial study design and feasibility to post-submission regulatory responses and everything in-between.

Can you guarantee FDA approval?

No — and no one should promise this. FDA decisions are independent and based on the totality of evidence, including the quality of your clinical data, study conduct, safety and efficacy results, and overall benefit-risk profile. What we can do is help you develop a clear, well-documented submission package aligned with current FDA guidance and help you identify and mitigate key regulatory risks. We can't control outcomes, but we can help you put your strongest evidence forward.

Do you have experience with breakthrough device designation?

Yes—our team has supported sponsors pursuing FDA Breakthrough Devices and other expedited programs. These important submissions demand tailored, pre-specified statistical strategies (e.g., efficient study designs, clear endpoint justification, and robust sensitivity/supplementary analyses). We’re experienced in developing regulator-ready methodologies and engaging early with FDA to align on evidentiary expectations and analysis plans.

What if FDA is requesting something unprecedented?

When the FDA raises questions that existing guidance doesn’t directly address, that’s where our experience matters most. We help teams develop fit-for-purpose analytical strategies grounded in established statistical principles. The must-haves include clearly justifying assumptions, pre-specifying methods, and documenting validation and sensitivity analyses to build an approach that is transparent, reproducible, and regulator-ready. We’ve supported multiple first-of-kind and novel submissions across FDA divisions, drawing on decades of experience with how FDA reviewers evaluate novel evidence.

Have you worked with FDA directly?

Yes — FDA engagement is core to what we do. Our team has supported numerous formal FDA interactions, including Pre-Submission (Q-Sub) meetings, IDE submissions, advisory panel preparation, and end-to-end support through review cycles. Our statisticians have also participated in FDA advisory panels representing device sponsors. We understand how reviewers think, what they prioritize, and how expectations vary across CDRH and CDER divisions.

Can you attend FDA meetings with us?

We have supported thousands of FDA interactions (including Pre-Subs, SIRs, Day 100, Informational meetings, Investigational Device Exemption [IDE], Type C, Submission Issue, Major Deficiency, Sprint Discussion, Interactive Review, Post-Market/Post-Approval Study, and Advisory Committee meetings). We develop statistical analyses and statistical portions of briefing materials, help anticipate likely FDA statistical questions, and join meetings as part of your team to support you in addressing technical/statistical inquiries as needed.

Can you handle our existing data?

Yes. We regularly work with data from many EDC systems and CROs. Our programming team can import, transform, and standardize data from a wide range of common formats (e.g., SAS, CSV, Excel, XML, JSON), subject to the availability of the appropriate exports and supporting documentation (data dictionary/codebook, transfer specs, mapping expectations such as SDTM/ADaM or sponsor-specific requirements). We help identify and address data quality issues through documented checks and traceable transformations—typically via queries and alignment with your team/CRO rather than making undocumented changes—and deliver analysis-ready datasets with clear provenance. We also support secure transfer and role-based access controls, aligned with applicable privacy/security requirements.

Do you provide QC for programming?

Yes. For client deliverables, we typically apply an independent QC step under a documented QC plan. Depending on the scope and risk, QC may include independent replication (double programming), peer code review, and automated checks/testing. We maintain documentation aligned with applicable regulatory expectations and client requirements to support inspection and audit readiness.

What software do you use?

We primarily use SAS and R — both widely accepted for clinical and regulatory submissions, including to the FDA. Programming for regulatory deliverables is performed in controlled, validated environments with role-based access, change control, and audit trails maintained per our SOPs and 21 CFR Part 11 requirements. We are also able to accommodate numerous other technologies (e.g., Python, SQL, CDISC tools, or sponsor-standard systems) if your program requires them.

Can you create the clinical study report?

Yes — we draft CSR statistical sections aligned with your SAP and sponsor templates, including tables, figures, and listings (TFLs) and the associated statistical Methods and Results text. We coordinate closely with your medical writing team to ensure consistency with the clinical narrative and formatting standards. Additional scope — such as SAP development, SDTM/ADaM and define.xml support, dataset builds, independent QC, or eCTD formatting — can be included and are confirmed upfront.

Can you work with confidential information?

Yes, data security is foundational to how we operate. All client information is considered proprietary and confidential. Client engagements require Non-disclosure agreements (NDAs) or equivalent agreements, and information handled with need-to-know access controls and encryption across all data channels. We are currently GDPR certified and are completing SOC 2 Type II certification to formally demonstrating enterprise-grade security capacity.

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What size projects do you handle?

What does BSC® specialize in?

What geographic areas do you serve?

What therapeutic areas do you cover?

What are your team's credentials?

What types of clients do you work with?

BSC® FAQs

Frequently Asked Questions

BSC® Insights

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