Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels.

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1 Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels.

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3 02 Clintrak knows how: Strategically engineered. Quality assured. Fully automated. Unmatched excellence. Streamlined. Completely controlled. elevating the standard to first time right. There is a patient at an investigator site that has to be able to read and comply with dosing instructions. They are brave enough to risk their health to advance your medical solution. Their safety and your company s reputation can only be ensured if clinical labels are delivered on time and in compliance with all regulations. Bob Scarth Vice President and General Manager, Clintrak

4 03 Strategically engineered. Your label is both the first and last word on the safe implementation of your protocol. Do your labels say what you need them to say? Are they staying where you need them to stay? Under any conditions? At every location? Anywhere around the world? For the duration of your trial? Legibly? Clintrak knows that safety is a strategic opportunity in the clinical development pathway. Using time-tested and experience-proven strategies, Clintrak confidently designs and delivers the right label for the right product in the right language to the right patient in the right country at the right time. In fact, clinical label experts at Clintrak have consistently innovated labeling services by improving turnaround speed, streamlining translation and approval processes, offering greater flexibility in labeling options, and enhancing quality control so that you can assure patient and site compliance. Proof is in Clintrak s results: Reduced cycle times by 50% Enhanced patient and site compliance Improved label Integrity Simplified administration of protocol and site changes

5 04 Clintrak reinvented the way the industry handles clinical labeling activities and elevated the standard to: First Right Time. Clintrak clinical label experts have defined and refined processes that have been tested so many times, costly risks and timelines are dramatically reduced for customers going global for the first or fiftieth time. Labeling services by Clintrak: Designed by experts to meet the unique needs of clinical trials. It s a level of security and confidence that comes only from delivering more clinical trial labeling in one month than others do in a year. Even when your resources are limited, Clintrak is expertly suited to integrate all your clinical labeling needs.

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7 06 Quality Assured. Every investigational study needs labels. Every product. Every comparator. Every visit box. Every shipping box. And unlike any other medical product, every clinical label is unique to every patient. In addition to directions for use, drug strength, storage requirements, and expiration, investigational labels must have what is necessary to allow every single dose to be tracked: package numbers, batch numbers, study identifiers, and unique subject identifiers that help cross-reference to drug reactions. Comparator packaging in blind studies must look identical to packaging for active drug, and provide distinguishing characteristics for the Sponsor. Patient identifiers must not be duplicated and assignments must be made to the right treatment groups. And then, each label has to have the right translation and meet the regional regulatory requirements of whatever country in which the investigational product is being tested. One mistake endangers both the patient and the trial, rendering study data useless. Dosage instructions can be translated inconsistently from one country to the next or get translated into a dialect a patient doesn t understand. Text mandated by country-specific regulatory requirements or variable identifiers may not make it to the right label. Challenging environmental conditions and repeated handling can degrade the label quality and legibility. How do you ensure that all patients receive the same set of instructions? Are you taking advantage of harmonized labels to reduce the potential for clinical trial variability? These strategic considerations drove the clinical label experts at Clintrak to leverage best practices in technology and automation to design several first-in-industry proprietary systems that stand unmatched in the clinical supply chain.

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9 08 Fully automated. ATLAS (Alternative Translation and Label Approval System) The industry s first clinical, web-based, label-specific translation and approval management system that comprehensively addresses the full spectrum of label development. Streamlining the process from text translation and approval through label manufacturing. ATLAS Offers validated, automated, and optimized multi-language label text development Ensures all patients receive identical instructions with clear, consistent language Is built on a proprietary, certified repository of globally consistent, multi-language terminology Exports text phrases 100% correctly every single time Improves text quality on labels by continuous vetting for quality and accuracy Integrates regulatory text approval from multiple countries, updated in real-time following real changes Eliminates the need for repeated translation steps Is customized with your specific common label translations Features a one-screen dashboard that tracks status and approvals of each label or text file, due dates, study contacts, and label text documents Routes, manages, and prompts foreign affiliates paperlessly for faster approvals Enables seamless oversight and proactive process management Assures compliance and accountability with electronic signatures

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11 10 Unmatched excellence. DigiPly The industry s first and only digitally produced booklet service supported by a dedicated team of Clinical Supply Professionals. Mitigating risk through proprietary, quality-driven technology and production processes, DigiPly: Features over 100 pages of available text in booklet label format Accommodates larger, easier-to-read font sizes Offers full color options to highlight critical text and insert relevant branding and logos Inspects 100% of black label text (fixed and variable) for accuracy and readability Identifies illegible text of any kind Protects data integrity with lamination and robust flexible-polymer construction to prevent smudging or damage in transit or through use Tolerates a wide range of temperature

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13 12 Streamlined processes. Creating a label for an investigational product is more than having an approved PDF file or document printed onto the appropriate stickers or pamphlets. But all too often time pressure and trial complexity result in shortcuts. That s why accurate clinical labeling happens less frequently than it should across the clinical supply chain industry. Often overlooked challenges cause delays if not managed well. Translating and approving clinical labels averages about 120 business days. Varying internal opinions on translations, while not wrong, can introduce a lot of discussion or debate that significantly slow the process. Additionally, experts anywhere can read regulatory requirements in different ways. When translations are performed manually, inconsistencies and errors on labels are frequent. For a large, multi-national trial, label text may require translation into dozens of languages. And up to 10 individuals in a single country may be needed to approve the translation. Any delays can prevent trials from starting on time and derail key milestone deliveries. Safety and assurance is best delivered through tightly integrated systems and standards that prevent the introduction of risk and delayed timelines at hand-offs. With the implementation of digital technologies, Clintrak develops label text, translates, harmonizes, and confirms compliance of labels with regional regulatory demands. Camera inspection of proofs for both common and variable text eliminates the impact of human error characteristic of the time-intensive manual inspection. This new generation of speed, quality, and control using proprietary systems and years of experience offer unprecedented accuracy and the shortest cycle times in the industry.

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15 14 Completely controlled. Recent investments have expanded Clintrak s capacity and improved label-production technology. With on-site presses focused only on clinical labels, Clintrak understands how to schedule to meet First Patient In dates. Whether the job is large or small, the same dedication is used to drive innovation and introduce a broader array of proprietary services that are matched to specific client needs. Offering clients bulk ordering to reduce cycle times and lower cost, as well as free temperaturecontrolled warehousing, has always set Clintrak apart. Resupply for the duration of a trial is as simple as pulling from inventory, applying quality controlled computerized variable print, and shipping out in days as opposed to weeks. With full-service labeling facilities in Bohemia, New York; Basel, Switzerland; and Ahmedebad, India, Clintrak has a global footprint with resources exclusively focused on the labeling of your investigational product. Clintrak is the market leader in clinical labeling design, label production, and label management services. Delivering the highest quality product in the fastest amount of time without re-work, Clintrak can dramatically improve the quality and cycle time of your studies anywhere in the world.

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17 16 Part of a team optimizing every step in the Clinical Supply Chain. Clinical trials require increasingly complex, global, clinical supply chain support. As part of Fisher Clinical Services, Clintrak supplements a dedicated clinical supply chain service provider and leverages purpose-built, integrated facilities, a global presence, and the information systems and flexibility to allow unparalleled visibility and control while offering time-saving, seamless transition opportunities throughout your clinical supply chain. Together, Clintrak and Fisher Clinical Services have developed most of the clinical supply chain industry s best practices through exposure to large multinational trials and thousands of protocols annually across all therapeutic areas for the past 25 years. In addition to Clintrak s labeling services expertise, Fisher Clinical Services offers manufacturing, packaging technology, and automation solutions that introduce time-saving, seamless transition opportunities throughout the clinical supply chain. From over-encapsulation to primary and secondary packaging or bottling to labeling, integrated services support every detail of manufacturing, packaging, labeling, and distribution seamlessly and cost-effectively with strict adherence to Good Manufacturing Practice (GMP). Patented technical capabilities throughout Clintrak and Fisher Clinical Services have been awarded the highest level of industry recognition enabling a quality systems approach to all critical processes in the clinical supply chain. The extended team of project managers and design engineers understands the impact of volume, geography, and distribution across any number of investigational sites and knows how to design solutions that best meet the needs of a clinical protocol. With a 25-year history and dedicated focus on clinical trials, Clintrak and Fisher Clinical Services are there for the patient who is waiting.

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19 18 Well connected. Clintrak is part of the BioPharma Services Division of Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science. With revenues of $13 billion, Thermo Fisher Scientific has approximately 39,000 employees and serves customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies, as well as in environmental and process control industries. The Company s strong base of talent is built on a cultural foundation firmly rooted in the 4-I values of Integrity, Intensity, Innovation, and Involvement. Thermo Fisher Scientific believes in not only attracting, but retaining the best people in the industry. Clintrak: Error-free labels in every language delivered every time on time, integrated with regulatory, packaging, and clinical logistics throughout the clinical supply chain. Products & Services Consultative Project Management Translation Services powered by ATLAS TM Label integrity with DigiPly TM Randomization Codes Label Proof Generation Blank Label Stock Multi-Lingual Booklet Labels (DigiPly & GlobalPly) Single & Multi-Panel Labels Blinded Labels Code Break Cards/Reports Tamper Evident Seals

20 Contact Us: North America Bohemia, New York (631) and toll free (888) Europe Basel, Switzerland Asia Ahmedabad, India