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CLINICAL TRIALS

PASSPORT TO THE WORLD WITH

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Early Phase Clinical Research

Early Phase Clinical Research

ABOUT PSI PSI is a leading full-service CRO specializing in ON-TIME DELIVERY of clinical projects across multiple therapeutic areas. Mapping out a clinical trial is much like setting out on a trip around the world. To enjoy it, you need to be sure to thoroughly plan your connections, have necessary visas in place, think of logistics, as well as local rules and practices. At PSI, we are keen to ensure that every step of your clinical project gets completed on-time and with utmost care for your needs.

Commitment to timelines and project ownership are hardwired into our people and processes. PSI’s exceptionally low staff turnover and remarkably high repeat business rates are consistent with PSI’s mission to be the best CRO in the world as measured by our clients and our employees. We enjoy what we do and invite you to take a trip through the clinical trial world with PSI. We’ll ensure that you’re ON-TIME and HAPPY throughout the journey.

DEVELOP STUDY CONCEPT REGULATORY CONSULTANCY FEASIBILITY STUDY COMPREHENSIVE PROJECT PLAN CREATE PROTOCOL CREATE CRF If found ,p s e conSTUDY SETleaUP DATABASE tact us : PSI CRO No rt h A STATS ANALYSIS PLAN me r ic a S a n Fra n c is c o SELECTION SITE Te l: +1 (6 50) 3 SET UP LOGISTICS 43 9STUDY 500 STUDY FILING WITH COMPETENT AUTHORITIES

ON TIME ON TIME ON TIME ON TIME ON TIME AHEAD AHEAD ON TIME ON TIME ON TIME ON TIME

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SITE CONTRACTS IRB APPROVALS Tel: +7 ( 812) 320 3820 INVESTIGATORS MEETING SITES ENROLLMENT READY SAFETY DATABASE AND REPORTING FIRST PATIENT IN INTERIM STATS ANALYSIS DSMB MEETINGS LAST PATIENT IN LAST PATIENT OUT RESOLVE QUERIES LOCK DATABASE FINALIZE INTEGRATED REPORT

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ON TIME ON TIME ON TIME ON TIME ON TIME ON TIME ON TIME ON TIME AHEAD AHEAD ON TIME AHEAD ON TIME

FEASIBILITY At PSI, Feasibility is a Department. Our 95% on-time project delivery metric is largely attributable to the effort and expertise that we invest into each new study, typically beginning at the RFP stage.

Led by a team of dedicated physicians, every project is given a thorough assessment by full-time feasibility staff. Our global experts examine criteria that include medical, regulatory, logistical and clinical aspects. This regional process ensures that PSI accurately predicts enrollment in different parts of the world.

Feasibility Completed: Ahead of schedule

Protocol Completed: On-Time

PROJECT MANAGEMENT On-time delivery is at the core of PSI’s Project Management Philosophy. PSI conducts full-service studies globally and pays special attention to delivering each project stage within predictable timelines.

By percentages, PSI employs more physicians in project management and operations than any other CRO, allowing us to maintain peer-to-peer relationships with investigators and site personnel.

Around the world, all PSI project managers are formally trained in management and communication skills, thus becoming experts in building effective interactions with sponsors, vendors and investigators. Not surprisingly, our project managers make PSI their career “home”. Once having experienced a project led by PSI, our clients return, giving PSI a remarkable repeat business rate.

Comprehensive Project Plan: On-Time

Investigators Meeting: On-Time

REGULATORY AFFAIRS Regulatory Affairs is a core competency within PSI, providing services at our global locations on several continents.

Regulatory experts are part of any clinical study at PSI, beginning at the RFP stage where regulatory requirements and timelines become an integral piece of projecting enrollment. Working closely with project management, Regulatory Affairs takes a lead role at study start-up to obtain country approvals for your study.

PSI’s Regulatory Affairs offers full-service support with CTAs, IMPDs, translations, local patient insurance, import and export licenses, drug labels, consultations with authorities, QP services and more.

Study Filings with Competent Authorities: On-Time

Sites Enrollment Ready: On-Time

MEDICAL AFFAIRS PSI’s Medical Affairs department is an industry-leading group of physicians with unparalleled clinical trial expertise.

Each project is assigned to a specialist who understands the protocol’s therapeutic area. These specialists monitor the medical aspects of the study, advising investigators and project managers when required.

Under the Medical Affairs umbrella, PSI delivers clinical study support that includes feasibility, medical consulting, medical monitoring, training, pharmacovigilance, laboratory support service and medical writing.

Medical Affairs at PSI can make a genuine difference to the success of your clinical trial, all beginning with the study feasibility, predicting enrollment for your study with refreshing accuracy. Then, close monitoring of subject eligibility results in a high percentage of evaluable patients.

Safety Database Set-up: On-Time

Site Selection: On-Time

Austria (Neusiedl am See)

LOCATIONS PSI operates around the world. Our largest offices are strategically located to support your clinical trial in the most sought after clinical trial locations.

Visit our offices in Zug, San Francisco, Philadelphia, Munich, Oxford, St. Petersburg, Moscow, Novosibirsk, Kiev, Prague, Warsaw, Budapest, Sofia, Bucharest, Belgrade, Minsk, Tallinn, Vienna and Buenos Aires.

France

Uruguay

Netherlands

Peru

Greece

Colombia

Slovakia Italy

Poland (Warsaw)

Brazil

Chile

Slovenia Armenia

Ecuador Sweden

Turkey

Finland

Russian Federation (Novosibirsk)

UK (Oxford)

Moldova

Lithuania Macedonia

Bosnia-Herzegovina

Norway

Russian Federation (St. Petersburg)

Spain Switzerland (Zug)

Japan Thailand

USA (Ft. Washington PA) Canada

First Patient In: On-Time

Belarus (Minsk)

Last Patient In: Ahead of schedule

USA (San Francisco CA) USA (Burlingame CA)

Last Patient Out: Ahead of schedule

Israel Serbia (Belgrade)

Taiwan

Malaysia

South Africa

Bulgaria (Sofia)

Kazakhstan

India

New Zealand South Korea

Montenegro

Russian Federation (Moscow)

Ukraine (Kiev)

Portugal

Croatia

PSI GLOBAL DESTINATION MAP

Estonia (Tallinn)

Czech Republic (Prague)

Mexico

Belgium

Germany (Munich)

Latvia

Argentina (Buenos Aires)

First Patient In: On-Time

Australia Hungary (Budapest) Georgia

Romania (Bucharest)

PSI Offices Operational Presence

Last Patient In: Ahead of schedule

DATA MANAGEMENT PSI’s Data Management Department is a cornerstone of our clinical trial services, staffed by experts with years of industry experience.

Our Data Management group consists of 40 professionals with years of experience at PSI and a long list of happy, devoted clients. Our data managers work closely and effectively with the clinical team every step of the way, from database development to on-time database lock. We are experts in the set-up of EDC studies on a variety of platforms.

STATISTICS Clinical Trial Statistics at PSI can help plan and govern every aspect of your clinical trial. Our PSI staff has an unrivaled depth of statistical knowledge and experience in study design and statistical analysis planning and execution.

Data from more than 40,000 patients have been analyzed by our team in the last several years, securing PSI uninterrupted statistical analysis business from repeat clients.

Our statisticians provide SAPs, final & interim analyses, ISS/ISE summaries, safety reviews for DSMBs, annual reports and other services.

Database Lock: Ahead of Schedule

Final Statistical Analysis: On-Time

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QUALITY MANAGEMENT PSI takes a global approach to quality management by recognizing the need for global compliance in any given program. Our staff is knowledgeable in local, national and international regulations and guidelines. Quality Management at PSI customizes the processes for each study depending upon the countries, agencies and vendors involved. In this way, problems are prevented or identified and corrected early on.

Our team takes pride in the positive outcomes from 40+ audits by the FDA and EMA. In addition to these, local authorities worldwide have verified data quality through numerous inspections.

The PSI Quality Management Department’s overall approach is one of collaboration and knowledge that creates an environment leading to successful and positive outcomes.

Quality Management services include training, vendor qualification, internal QA audits and hosting agency site audits.

Agency Site Audits: No Findings

Internal Study Audit: No Findings

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Customs Broke rages Planning and managing Investigator meetings

IT Support

TRIAL SUPPORT SERVICES PSI provides an impressive global infrastructure for clinical trial services, working in synergy with clinical operations, to handle the technical aspects of each clinical trial we undertake. However complex, PSI is uniquely qualified to help.

Support Services include central lab assistance, courier and vendor supervision, investigator meeting planning and management, legal support for CTAs, customs brokerage, IT Support and translation services.

CE CENTRAL LAB ASSISTAN Legal Support for CTAs

Courier vendors Set up Study Logistics: On-Time

Clinical Trial Agreements: Ahead of Schedule

Services provided cover drug supply life cycle management, drug labeling, import/export coordination, global distribution of study drug, drug reconciliation & destruction and controlled storage warehouses.

GLOBAL DISTRIBUTION OF STUDY DRUG

LIFE CYCLE MANAGEMENT

DRUG LABELING

DRUG RECONCILIATION & DESTRUCTION

Drug Depot Set up: On-Time

CONTROLLED STORAGE WAREHOUSES

IMPORT/EXPORT COORDINATION

Import/Export Coordination: On-Time

Early Phase Clinical Research

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PSI offers a comprehensive range of clinical supply services throughout the world. PSI has drug storage facilities in the European Union, Russian Federation and Ukraine to facilitate the conduct of clinical trials in these regions. For our non-EU clients, PSI serves as a point of entry for investigational products entering the European Union.

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CLINICAL SUPPLY MANAGEMENT

THERAPEUTIC EXCELLENCE With our 250 MDs on board, PSI has commendable expertise in a variety of therapeutic areas that include pediatrics and orphan indications. PSI is known to provide strong medical support throughout project planning and execution. Medical science is our passion, which explains why PSI has attracted medically-qualified ABOUT PSI staff worldwide.

PSI is a leading full-service CRO specializing in ON-TIME DELIVERY of clinical projects across multiple therapeutic areas. Mapping out a clinical trial is much like setting out on a trip around the world. To enjoy it, you need to be sure to thoroughly plan your connections, have necessary visas in place, think of logistics, as well as local rules and practices. At PSI, we are keen to ensure that every step of your clinical project gets completed on-time and with utmost care for your needs.

Commitment to timelines and project ownership are hardwired into our people and processes. PSI’s exceptionally low staff turnover and remarkably high repeat business rates are consistent with PSI’s mission to be the best CRO in the world as measured by our clients and our employees. We enjoy what we do and invite you to take a trip through the clinical trial world with PSI. We’ll ensure that you’re ON-TIME and HAPPY throughout the journey.

On-Time Enrollment

250 Physicians On-Board

On-Time Project Delivery

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