DEDICATED ONCOLOGY OPERATIONAL AND SCIENTIFIC TEAMS

The competitive landscape for oncology research is at an all-time high, and trial designs are increasing in complexity. Recent reports indicate that the success rate of investigational compounds approved for clinical use in cancer is the lowest among all diseases, and the likelihood of approval for investigational oncology drugs tested in Phase I trials is only 6.7 percent1. Who you select as your CRO partner can have a significant impact on the success and/or failure of your clinical study and program. Who can you trust to help you with your development journey?

With Worldwide, you get the best of both worlds: A specialized oncology CRO with global coverage. We’re a full-service, midsized CRO with therapeutic experts who have earned reputations for taking on the most complex and challenging cancer research studies. We offer a global footprint – without the hefty price tag and cookie-cutter approach you get from large, consolidating CROs.

Our award-winning, specialized early phase oncology team helps emerging and established biopharma, biotech and pharmaceutical companies accelerate the advancement of early phase compounds through clinical testing.

YOUR CANCER THERAPY SHOWS PROMISE. GET ON YOUR WAY TO FDA APPROVAL FASTER AND EASIER WITH WORLDWIDE.

YOU’RE MORE THAN A MOLECULE TO WORLDWIDE. OUR MEDICAL, SCIENTIFIC AND OPERATIONAL EXPERTS TAKE YOUR CORPORATE GOALS PERSONALLY.

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1,600

63

+

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Real Offices in Emerging Markets for Access to Hard-to-Find

Oncology Patients Across

Professionals

Countries

From the moment of involvement in the study, we felt Worldwide’s support, experience, knowledge

and ability to help in difficult situations. All the materials, trainings, meetings organized by Worldwide personnel within the study were very helpful and informative.”

- Investigator, Cancer Center

GLOBAL REACH FOR FASTER RECRUITMENT AND START-UPCancer spans the globe. Frequently, cancer therapies are targeting small subsets of patients with rare mutations or patients that have been treated with a very specific therapeutic regimen. Our long-term relationships with successful, experienced sites and oncology centers worldwide help us recruit patients faster than ever before, accelerate study start-up and navigate the global regulatory landscape to expedite approvals.

Worldwide Clinical Trials opened a site in Germany in

record time – fewer than 3 months from the first contract day to the initiation visit. I am very pleased with the expedited work done by Worldwide. Job well done!”

– Worldwide Customer

(Global Project Management)

Data Quality, Meeting Overall Project Timelines, Technology for Real-Time Access to Data, Operational Excellence, Responsiveness

+1 610 964 2000 | WORLDWIDE.COM1 Pharmaceutical Research and Manufacturers of America. Medicines in development: Cancer [online], 2014. Available at http://www.phrma.org/sites/default/files/pdf/2014-cancer-report.pdf.

FLEXIBLE, EFFICIENT OPERATIONS FOR UNCOMMON VALUE

A SPECIALIZATION IN EARLY PHASE ONCOLOGY PROGRAMS FOR ACCELERATED TRIALS

When timing is critical and every day delayed can cost millions, Worldwide’s simple, thorough, streamlined operations are critical to your oncology development program.

Whether your study is a small, focused single-region trial or a study that requires global reach, we designed our specialty oncology team – oncologists, experienced clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts – to work collaboratively with you to help you overcome the high-risk, high-cost, time-intensive challenges of early phase oncology drug development.

• Flexibility to manage study size, trial speed and patient access.

• Automated technologies and systems to eliminate traditional bottlenecks in the flow of clinical data – expediting your trial while keeping costs down.

• Dedicated feasibility and clinical science start-up team that uses predictive analytics to speed recruitment and drive enrollment.

• Strategic alliances with the world’s largest network of accredited panels, experienced board members, and thousands investigators and institutions – enabling us to assemble knowledgeable resources quickly, for a smoother, faster, less expensive path for your trial.

• Timely, accurate and transparent communications by our operational teams with the support of eClinical tools (e.g., EDC, CTMS, eTMF, Safety) for performance and risk management.

• We’ve conducted research in a full range of solid tumor and hematologic indications and therapies – from traditional cytotoxic agents to cutting-edge targeted therapies.

• We work with you to customize your protocol and study design for an optimal outcome. Our goal is to get you through the critical early stage of testing and on your way to FDA approval, with the shared mission of meeting and exceeding deadlines to bring lifesaving drugs to market faster.

• With Worldwide, you get a committed executive management team, engaged at all times throughout the course of your program to help ensure the successful execution and delivery of your trial.

• Our relationships with key oncology opinion leaders provide you access to vital counsel – critical to understanding your product’s life cycle as well as what is required to accelerate your treatment to market.

A sincere thank you to everyone for their hard work and dedication to make this happen on such a condensed timeline. It’s a major milestone for our company but more importantly for potential patients.”

Source: ISR Reports CRO QUALITY BENCHMARKING – PHASE I SERVICE PROVIDERS (8TH EDITION)

Rated Top Performer Service Providers Performance and Loyalty for “Budget Factors” – attributes include Low Cost and Minimizing Change Orders.

“Worldwide Customer (Clinical Operations)

+1 610 964 2000 | WORLDWIDE.COM

Meghann Howland

Leslie Wetherell

Dr. Mireille Cantarini

Many large CROs offer “off-the-shelf” advice and solutions to their customers. Worldwide delivers tailored and pragmatic advice, regardless of the size or complexity of the project. Our collaborative, customized project teams with phase- and indication-specific expertise develop successful strategies for even the most novel therapies.

Vice President - Therapeutic Area Operational Strategy Lead, Hematology/Oncology

Executive Director, Oncology/Rare Disease

Medical and Scientific Affairs

Meghann Howland brings more than 25 years of clinical and research experience in a variety of early phase hematology and oncology trial designs to your trial. She is well versed in adaptive, continual reassessment methods, Bayesian, basket and umbrella trials, in addition to traditional “three plus three” dose escalation and Simon two-stage designs. Her extensive experience covers traditional cytotoxic, monoclonal antibodies, CART-T cell, gene therapy and oncolytic viral therapy. See here for the extensive list of oncology indications that make up Meghann’s breadth of work – work that better enables her to effectively guide sponsors to optimize their programs.

With 20-plus years of experience, Leslie Wetherell is responsible for Worldwide’s portfolio of rare disease studies, including complex rare oncology studies. She has driven global strategy, implementation and risk mitigation for over 40 studies and five programs submitted for NDA submissions and has operational experience in over 40 countries. See here for Leslie’s extensive list of hematology/oncology and rare disease experience.

Dr. Cantarini brings a long history in clinical research to her role as medical and scientific affairs consultant at Worldwide. Sponsors focused on oncology appreciate her experience with the Oncology Early Clinical Development organization at AstraZeneca where she was involved in Phase I/IIb studies across several cancer indications across global locations (including the EU, US, Southeast Asia, Japan, South America, South Africa and China). Most recently, Dr. Cantarini was involved as Executive Medical Director in the Osimertinib (indication T790M-positive non-small cell lung cancer (NSCLC)) program, taking the clinical development from first dose-in-human to full regulatory approvals in all major territories (FDA, EMEA, Japan and China) in four years. She has been board certified in Pharmaceutical Medicine (GMC specialist register) since 2005 and has a 30-plus-year record of publications in peer reviewed journals.

THERE’S NO SUBSTITUTE FOR UNCOMMON EXPERTISE. MEET YOUR PARTNERS.

+1 610 964 2000 | WORLDWIDE.COM

THE CURE FOR THE COMMON CRO

We are honored to be recognized by our customers for excellence in CRO Capabilities, Compatibility, Expertise, Quality, and Reliability

It’s hard to put a finger on what, exactly, makes Worldwide different from other CROs — but you start to get it when you experience the passion, expertise, and commitment in every team member.

We put everything into our projects.

Our dogged determination to get it right. Our spirit of invention. Our rigorous processes. Always curious. Always dedicated to delivering quality data.

It keeps our customers coming back, choosing Worldwide as their partner time after time. From bioanalytical lab services, to early phase, late phase, and real-world evidence studies, we’re out to change how the world experiences CROs — in the best possible way.

Learn more at WORLDWIDE.COM

FULL-SERVICE, AWARD-WINNING CRO SERVICES Bioanalytical Services | Phase I-IIa | Phase IIb –III Phase IIIb-IV | Real-World Evidence | Rater Services

THERAPEUTIC FOCUS AND EXPERTISE Central Nervous System | Cardiovascular and Metabolic Immune-Mediated Inflammatory Disorders Oncology | Rare Diseases