Science Driven CRO

Science Driven CRO

europital.com

Europital is an international Contract Research Organization (CRO) providing a full range of clinical services for the pharmaceutical, biotechnology and medical device industries and governmental and scientific Institutes.

Founded in 2010, Europital is a new type of a CRO that features Medical Science at its heart, coupled with an unwavering commitment to quality, efficiency, and operational excellence. Acting not as a service provider, but as a true partner to our clients; we think, work and deliver success together. We have delivered Global projects, reaching all continents and exchanging knowledge, adapting to new markets and building lasting partnerships.

Our success has provided Europital with a repeat business rate of nearly 100%, as our clients trust in us to deliver deep therapeutic knowledge, a scientific approach and flexible delivery every time. Our team share in our vision and commitment, with each team member dedicated to the rigors of a scientific mindset, systematic approach and creative, science-driven solutions. Most importantly, we understand your success and return on investment is dependent upon our commitment to science.

Our experienceSince 2010, the Europital team has been working across many Therapeutic Areas including Oncology, Infectious Diseases, Inflammatory Diseases, Immunology, Cardiology and Respiratory Diseases covering a wide range of disease indications both in

adult and pediatric cohorts. Our experience covers First In Human (FIH) studies, both in patients and healthy volunteers, to large Pivotal International studies conducted across multiple continents.

178 Studies

44,916 Patients

102 Countries

Therapeutic areas Study phase Ph I 20%

Ph II 28%

Ph III 39%

Ph IV 13%

Oncology Neurology Gastroenterology Respiratory Diseases Immunology Cardiology Inflammatory Diseases Infectious Diseases

Science Driven CRO 32 Europital

Therapeutic Areas and Study PhasesFeatured Diseases Indications experiences

Oncology: Breast, CRC, HCC, NSCLC, Ovarian, Prostate, Lymphoma, Melanoma, and Gastric Cancers

Hematological cancers: ALL, CLL, AML, MDS, and MF

Infectious Diseases: HIV, HAV, HBV, HCV, RSV, Tetanus, Influenza, and TB

Inflammatory and Autoimmune Diseases: RA, AS, Psoriatic Spondylitis, Crohn’s Diseases, UC, ITP, IPF, and SLE

Cardiology: AF, MI, Cardiac Arrhythmia, and ACS

Medical Device: Morbid Obesity, Corneal Transplantation, MI, and Breast Cancer

Why Europital?

Services

1Europital is founded on medical science, and quality is our trademark; ensuring the quality of your study and robustness of your data is our top priority

2At Europital, we know that each study is unique, and we establish a project-specific roadmap built on efficiency, flexibility and creative thinking to ensure operational excellence

3As a reliable partner who will share responsibility and accountability, we go the extra mile with all our clients to ensure success

Medical Affairs

Clinical Operations

Biometrics

Pharmacovigilance

Regulatory Affairs

Medical Writing

Europital is founded on Science and Quality is our trademark

Medical Affairs

The Research Physician is a vital member of any drug development team and forms the backbone for all medical and scientific aspects of clinical research projects. Our Research Physicians perform expert medical reviews of clinical and safety study documents, accumulating the most robust data and associated reports to deliver the most scientifically valuable conclusions.

A key part of our approach is to nurture Physician- to-Physician scientific interactions with the sites. It’s why Europital medical liaisons provide continuous site engagement via scientific interactions with investigators and site staff that facilitate essential knowledge transfer and resolve potential study obstacles before they occur.

• Medical Expertise from concept to conclusion• 24/7 Medical Monitoring• Medical Review of documents and data• Medical Liaison and site engagement• Medical and Scientific Training

Scientific and Medical Guidance

Through an intuitive interface – Interactive Guidance Management System (IGMS) PenThu®– responsible physicians and study leads seamlessly provide medical and scientific guidance to the broader study teams across multiple projects. Medical questions and guidance requests are automatically processed and managed in the IGMS via its interactive dashboard. The delivered guidance is then automatically and instantly made available for the entire team via both an online search and a formatted, downloadable Q&A Log.

Role of Medics

Data SMP

DesignCRF MMP

Protocol

AnalysisTFLs

ASR

CSR

Narratives

AE

IM

DSUR

SAE

GuidanceDBL

IB

Q&A

Eligibility

ICF

PDs

Training

Review

Investigational site requests guidance1 Monitor request guidance from Responsible Team4 Answer found in existing project-specific knowledge baseA

Monitor consults project-specific knowledge base2 Digital round-table team deliberation to establish guidance5 Answer provided to monitor & knowledge base updatedB

Monitor searches established answers & guidance documents3 Monitor provides requested guidance to siteC

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Clinical Operations

The Clinical Operations team ensure timely and efficient planning, execution and conclusion of each clinical trial.

Project Management

With a broad experience in drug development and clinical research in multiple disease indications, the Europital project management team ensures appropriate planning, efficient execution, and timely conclusion of your clinical project.

We adopt an agile management approach with the expert Core Team assigned to each project, assuming full responsibility of organization and execution of the project together with guidance, coordination and supervision of regional and local operation teams

• Primary point of contact to sponsor• Project planning and implementation with full

oversight and coordination of various activities• Ensuring compliance with ICH-GCP, applicable

regulations and SOPs, and the study protocol

Clinical Monitoring

Our monitors take full responsibility for checking that the correct protocols are followed by investigational sites, ensuring the integrity of data recorded and protecting the study participant’s wellbeing. All information is then imminently reported to Project Management, with suggestions for CAPA.

• Feasibility and Site Identification • Site Initiation and Management

• Study Monitoring: onsite visits, virtual, remote and wearables

• Site communication and project-specific training • Accountability for sites’ study documents and materials

Technology Integration

By combining science and state-of-the-art technologies, Europital optimizes each step in the clinical trial process whilst maintaining the highest regulatory standards, the safety of the patients, and the scientific integrity of the data collected.

Our seasoned project managers utilize their technology management capabilities to integrate the most advanced clinical research technologies in the daily clinical trial operations to ensure quality and efficiency.

Clinical Monitoring Safety

Project Management

Financial Medical PV RA

Stats R&D Legal C

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Vendor

DM

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Patie

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Inv

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Stee

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Com

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Biometrics

Optimal data management, programming and statistical analyses processes are pivotal to reducing the time and cost of drug development. Improvements that can be made by implementing the most appropriate and advanced measures available for designing, collecting, analyzing, converting, and reporting clinical research data throughout the drug development process result in objectively higher data quality. Our biometric services provide submission-ready trial results with an assurance of scientific integrity.

Biostatistics

From trial design to clinical trial reporting at Europital, we provide a modular approach adapted to the specific needs of your project. Delivering expertise in biostatistics for trials from Phase I–IV and advice on a single issue through to statistical coverage for an entire project from concept to regulatory submission and defense.

• Statistical input to protocols, including overall strategy and sample size calculation

• Preparation of the Statistical Analysis Plan (SAP)• Adaptive design and group sequential strategies• Innovative analyses, such as Lag-time analysis• Interim analyses and Exploratory post-hoc analyses• Full integration of CDISC

Data Management

Rigorous and comprehensive Clinical Data Management is critical for the success of clinical trials. To ensure your trial generates high quality, scientifically valid and statistically sound data, our experienced data managers will be part of your clinical development strategy and reliably increase your trial capabilities from the planning stage, through to execution and beyond.

• Clinical database design, testing, and implementation • Development of the data management plan and data

validation plan • Case report form (CRF) design either with electronic

data capture (EDC) or paper • Medical coding • Data entry and data review • SAE reconciliation and discrepancy management • Oversight, management, uploading and review of

third-party data • Database lock activities

Regulatory affairs

Regulatory affairs provide strategic, tactical and operational direction to ensure compliance with applicable regulations to expedite the development and delivery of safe and effective products.

By optimally planning and implementing appropriate and tailored regulatory strategies for your clinical development plan, Europital can lead you through successful interactions with authorities and accelerate your product towards approval.

• Regulatory Document Writing, such as Dossier Content and Annual Reports

• eCTD preparation, publishing and submitting through electronic portals

• NDA, BLA, MAA writing, compilation and submission• Preparation, Management, and Submission of

Regulatory Dossiers (INDs, CTAs, MAA, BLAs, and NDAs)

• Strategic guidance and support for FDA and EMA meetings

• Gap Analysis of Regulatory Data• Regulatory Filing Strategies and Designation

Requests, such as Orphan, Fast-Track and Breakthrough

• Facilitate and attend agency and Scientific Advice Meetings

Quality, efficiency and operational excellence drive our daily activities

Science Driven CRO 76 Europital

Pharmacovigilance

The Europital team of Pharmacovigilance (PV) scientists together with our safety physicians support pharmaceutical, biotech and medical device companies to ensure patients’ safety and meet regulatory requirements via the appropriate setup and implementation of all aspects of PV.

• Setup, Managing and Maintaining Safety Database • Adverse Event management and expedited reporting • ICSR Processing and Reporting • Aggregate Safety Reports preparation and submission • Literature Search • Risk Management • Eudravigilance setup, registration and reporting

EU QPPV

Medical Writing

Europital’s medical writing experts can provide you with a significant advantage when it comes to communicating the efficacy and safety of study treatments. Our team can manage projects efficiently and provide a clear and logical account of studies to help communicate these key messages throughout the initial registration, clinical trial cycle and beyond.

Clinical Regulatory Documents (Phase I – IV)

• Clinical Study Protocol • Clinical Study Report (CSR) • Patient and Safety Narratives • Investigator Brochure (IB) • Clinical Development Plan • Standard Operating Procedures (SOP) • Investigational Medicinal Product Dossier (IMPD) • Common Technical Document (CTD) Modules

Medical Device Documents

• Clinical evaluation reports (CERs) • Post-market surveillance plans • Post-market surveillance reports • Periodic Benefit-Risk Evaluation Report (PBRER) • Summary of safety and clinical performance (SSCP)

Medical and Healthcare communication documents

• Primary Publications • Reviews and book chapters• Event documentation for Expert Meetings and more• Conference and congress abstracts and posters• SEO-optimized website content and online articles • Patient information and self-help resources • Medical education and training media

The scientific value of your results defines your ROI

PenThu®, the first Interactive Guidance Management System (IGMS) in the clinical research industry developed by Europital. It is an intuitive platform enabling you the means to smoothly provide study guidance and manage guidance issues across multiple projects with minimal effort, saving time, energy and resources.

With the unique icon-driven dashboard, the IGMS enables you to stay on top of important issues and effortlessly navigate actionable items at a glance. PenThu® automatically prioritizes and classifies all guidance requests and questions, minimizing time wasted sorting non-relevant communications. With the customizable notification system, any urgent requests, actionable items, and updates are automatically sent by the IGMS to the designated team members ensuring timely actions.

PenThu® is continuously developed by Europital’s seasoned clinical research professionals and founded on three core principles:

• Creating, managing and deploying all guidance resources to the entire study team

• Providing team members global access to a searchable study-specific guidance repository with a means to request new guidance to the Responsible Team Members

• Overseeing, tracking and measuring the progress of the project and the performance of the team

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Geographical CoverageWith our global experience and international capabilities, we ensure efficiency and operational excellence in your project in 4 continents covering Europe, US, Russia, India and MENA region.

Europital Headquarters • Lieven Duvosellaan 15, 9830,

Belgium

Europital Regional Offices• Belgium, 9000 Ghent, Van

Rysselberghedreef 2 • UK, Oxford, 265 Cowley Road,

Oxfordshire, OX4 1XQ• Hungary, 1051 Budapest,

Széchenyi István tér 7

Europital Trusted Partners Locations• US, California• Russia, Saint Petersburg • India, Mumbai• Egypt, Cairo• Israel, Rosh Haayin• UAE, Dubai • Australia, Thebarton

Let us know how we can help you drive your clinical trial project forward

Dave BruceBusiness Development Manager dave.bruce@europital.com M. +44 7850 123151

EuropitalICC Building Van Rysselberghedreef 2 9000 Ghent Belgium Tel. +32 9 3316030 info@europital.com europital.com

We think and act not as a service provider but as a true partner to our clients where we think together, work together and achieve success together

General contact

Science Driven CRO 1110 Europital

Science Driven CRO

Science Driven CRO

europital.com