A Proven Partner for Biostatistics in Clinical Development

Statistically Speaking – We’re Above Average in Experience

Each of our biostatisticians brings an average of 20+ years’ experience, setting a higher standard than most organizations.

Transforming Clinical Data into Regulatory Success

Summit Analytical, a wholly-owned division of Lotus Clinical Research, delivers biostatistics, statistical programming, and PK/PD modeling and analysis services grounded in deep expertise and scientific precision. Our senior staff provide sponsors with exceptional depth in trial design, analysis, and regulatory support—across all phases and therapeutic areas.

Our long-standing partnership with Lotus means sponsors can engage with Summit in a flexible Functional Service Provider (FSP) model or as part of a full-service CRO solution. In either model, we work seamlessly with your team to provide:

High-quality analyses tailored to your protocol
Sound, scalable solutions to complex statistical challenges
A collaborative, responsive approach designed for your trial’s success

Integrated Clinical Development from Sites to Submission

Working with the combined expertise of Summit Analytical, Lotus Clinical Research, and ERG offers a powerful advantage: fully integrated, end-to-end clinical development support—from sites to submission. This alliance brings together deep statistical and analytical expertise (Summit), full-service CRO capabilities (Lotus), and direct access to patients through a leading site network (ERG). Together, we deliver comprehensive, end-to-end trial support—from protocol design and statistical consulting to full-service CRO operations and high-performing site execution.

Whether you need standalone services or a fully integrated model, this alliance offers unmatched flexibility and efficiency. Sponsors benefit from seamless collaboration, centralized oversight, and faster, smarter execution—all from trusted, experienced partners.

We’ve Got You Covered:

Geographically & Therapeutically

With team members across the U.S., Canada, Mexico, Europe, and Asia, we offer global coverage and extended work-day capabilities—adding speed and flexibility to every engagement.

We believe every client deserves high-quality, timely, and expert statistical services—no matter their size. We’re large enough to provide comprehensive statistical advice and deliverables, yet small enough to offer personalized attention.

Our PhD biostatisticians are experienced in pharmaceutical, biotechnology, device, and nutraceutical development across a full spectrum of diseases and therapeutic areas including:

Cardiovascular

Dermatology

Gastrointestinal

Musculoskeletal

Neurology

Oncology

Ophthalmology

Pain

Psychiatry/Psychology

Rheumatology

Meet the Leaders at Summit Analytical

Mark Jaros, PhD

Sr. Vice President

25+ years experience covering regulatory and study design consulting.

Lance Ballester, MS

Director, Biostatistics

10+ years experience including early and late phase trials, pediatric studies, and extensive programming.

Shereen Khwajazada, MBA

Director, Biometrics

Nine years of experience in biometrics technical support, project management, and leadership; currently serving as the PhUSE US Special Projects Director.

Kalpana Raman

Director, Process & Sourcing

20+ years of extensive experience in clinical development operations, and business development.

Phil Shale, PhD

Director, Biostatistics

Special projects and consulting in biostatistics for 25+ years.

WHY Sponsors Choose Summit Analytical for Specialized Biostatistical Expertise

We bring a passion for precision and a commitment to excellence in every statistical deliverable. Built on advanced data science principles, our biostatistical services form the strategic backbone of clinical development—where clarity, rigor, and experience can define regulatory outcomes.

What Sets Us Apart

Protocol Design Excellence

We engineer statistically sound study designs that maximize power, reduce risk, and align with regulatory expectations from day one.

Regulatory Intelligence

Our global regulatory insight ensures your statistical strategy anticipates agency needs and stands up to scrutiny.

Analytical Precision

Meticulous attention to detail in data calculations ensures accuracy and integrity throughout the development process.

YOUR Competitive Edge: OUR People

Top Talent, Always

We invest exclusively in top-tier statistical talent, which means your project is handled by elite statisticians with deep therapeutic and regulatory expertise.

Non-stop Learning

We continuously invest in training and advancing our team’s competencies, maintaining a gold standard of biostatistical excellence.

Proven Impact

With a track record of successful submissions, we know what it takes to turn data into decisions and trials into approvals.