About CATO SMSWith more than 30 years of global experience, our team is optimized for small and emerging biopharma sponsors like you. Our specialists deliver innovative regulatory consulting solutions to guide you through the most complex regulatory challenges. Our expert teams effectively design and execute clinical trials — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas with a commitment to making trials digital.

Our combination of regulatory, therapeutic, and operational expertise enables us to meet your challenges and seize opportunities that arise before or during study conduct.

Whether you need experts in medical affairs, regulatory consulting services, clinical trial management, or biometrics, we can help you meet your goals.

High stakes require high performance. Partner with the experts at CATO SMS.

With offices across North America, Europe, and the Middle East, CATO SMS has experience

conducting trials in more than 25 countries, focusing on some of the most complex drug

development areas, including oncology, rare and orphan indications, and cell and gene therapy. CATO-SMS.com

High-Performance Services and SolutionsCATO SMS experts deliver specialized product development services and solutions, designing and executing studies in complex indications and modalities. Our extensive regulatory affairs experience in clinical research enables us to deliver innovative strategies and consulting insights as you navigate the approval process.

CATO SMS’ knowledgeable experts tackle your toughest challenges with confidence and precision in areas including:

• Clinical Trial Operations

• Regulatory Consulting

• Medical Affairs & Pharmacovigilance

• Data Management

• Biostatistics & Statistical Programming

• Strategy & Consulting

• Preclinical/Nonclinical

We provide valuable insight, high-quality deliverables, and unmatched client service, giving small and emerging biopharma companies like yours expert guidance to identify specialized solutions you need, every step of the way.

Count on CATO SMS to navigate complex regulatory requirements with more than 30 years of global experience, ensuring

effective and efficient NDA, BLA, IND, and CTA filings as well as meetings with the FDA, EMA, and country-specific governing authorities.

Clinical Trial Operations Rely on our expertise and our proactive, responsive, and pragmatic approach tailor-made to match the specific needs of your project. With global experience in effectively designing and executing studies, we are your partner from strategy to approval in complex indications and modalities across a variety of therapeutic areas and patient populations.

Benefit from these options, either singly or as a full-service solution:

• Protocol Development & Study Design

• Patient Recruitment

• Study Startup & Feasibility

• Clinical Project & Program Management

• Site Management & Clinical Monitoring

• Medical Services

• Pharmacovigilance & Safety

• Clinical Trial Oversight

CATO SMS has supported more than 500 clinical trials worldwide, from Phase I through Phase IV, contributing to the successful development of more than 50 marketed products.

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Regulatory & Development Consulting CATO SMS delivers on complex development programs requiring innovative regulatory strategies for the pharmaceutical, biotechnology, and medical device industries. Leverage our global team’s track record of successful interactions with regulators on a wide variety of products and technologies. We offer:

• Product development strategy and planning

• Target product profile (TPP)

• Clinical development planning

• Regulatory development strategy and submissions

• Clinical pharmacology

• Nonclinical/safety strategies

• Gap analysis, critical risk identification, and contingency planning

BiometricsCATO SMS is committed to providing the highest quality services for you. Our global biometrics group is a dedicated, experienced team of biostatistics, statistical programming, and data management professionals devoted to delivering individualized, adaptable, and dedicated services to support all of your data and analytical needs. We offer:

• Biostatistics and statistical programming

• Statistical analyses

• CDISC: SDTM and ADaM

• Regulatory support, representation, and submissions

• Statistical consulting and development strategy

• Statistical analysis plans

• Data monitoring committee (DMC) and scientific review committees

• CRO management and oversight

• Data management

• Cloud-based EDC systems

Committed to Support Decentralized Trials• Actively supporting and enabling

decentralized clinical trials (DCTs) and virtual visits

• Strategizing and implementing the best digital approach for your trial

• Working with leading technology platforms and tools, including THREAD, to enhance your study design and conduct

• Maximizing the effectiveness of your development and minimizing risks

Our regulatory experts are seasoned professionals

who have significant work experience within the medical device, pharmaceutical, and biotechnology industries,

collectively participating in the development of more than

50 approved products.

CATO SMS Therapeutic ExpertiseCATO SMS team members are experts in clinical trial management with decades of experience designing and executing clinical trials in complex indications and modalities, such as:

Additional Areas of Focus• Infectious Disease

• Endocrinology & Metabolic

• Cardiology & Vascular

• Dermatology

• Respiratory & Pulmonology

• Nephrology & Urology

• Obstetrics/Gynecology/Women’s Health

• Pediatrics

• Device & Diagnostics

We treat your drug development journey as if it’s our very own, providing valuable insight, unmatched client service, and high-quality deliverables.

Oncology & Hematology

Rare & Orphan Disease

Cell & Gene Therapy

Central Nervous System

Gastroenterology & Hepatology

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Medical AffairsAt CATO SMS, M.D.s/Ph.D.s are available 24/7 to provide site support and answer medical questions. With experience across therapeutic areas, the medical affairs team is a key contact for your principal investigators (PIs).

To ensure patient safety and data integrity, we:

• Perform a full medical review, including protocol deviations.

• Share clinically relevant trends with sponsors.

• Continuously assess therapeutic response.

• Interact with CRAs to identify safety issues early.

• Set up and chair boards and committees.

PharmacovigilanceCATO SMS delivers fully compliant and high-quality, comprehensive pharmacovigilance services for Europe and North America. Our pharmacovigilance managers (PVMs) are certified by the EMA as EVWEB and XEVMPD users in the EudraVigilance system.

Be confident with our safety handling and reporting activities:

• Setup and maintenance of trial-specific and/or global safety database

• Registration of sponsor and product in EudraVigilance registrations

• Processing and (cross-)reporting of SAEs and SUSARs

• Writing of safety narratives

• Periodic aggregate safety reporting (e.g., semiannual line listings, DSUR)

• Safety coding (MedDRA, WHODrug)

• SAE reconciliation

• Moderation/facilitation of IDMC meetings

• Updating of IB with new safety information

• Blinded/unblinded services

• Qualified person for pharmacovigilance/responsible person (QPPV/RP) for EudraVigilance

We know how important your product is to you and the patients who are waiting.

info@CATO-SMS.com

North American Headquarters2000 Centregreen WaySuite 300Cary, North Carolina 27513+1 919-361-2286

European HeadquartersStationsplein Noord-Oost 4381117 CL SchipholThe Netherlands+31 20-4350-580

CATO-SMS.com