CRDE company was founded in 2002 as CRO focused on CEE region. Founders are the people with many years of experience in clinical trials, gathered in the top international pharmaceutical companies and CROs. We have strong practice and know-how of clinical research standards and current technology.

CRDE provides highly comprehensive services for clinical trials phase I - IV. We offer management of clinical trials from single studies, country specific projects to complex, international ones in a broad range of therapeutic areas through Central and Eastern Europe.

Our employees are professionals with life sciences degrees, MDs, DVMs, clinical trials know-how, all have undergone our extensive training programs. CRDE is known for its quality, professionalism, flexibility and enthusiasm.

Studies and their organization are in accordance to the Polish law and ICH-GCP guidelines, EMEA and FDA standards. Maintaining global ICH-GCP standards is possible thanks to constant personnel training. We operate according to our own SOPs or delivered by study sponsor.

Through collaboration with us you will discover highest quality standards with highest recruitment rates for reasonable costs as well as local expertise.

We are convinced that cooperation with us will benefit your company

Marek Kiersznowski, General Manager

• Patients are highly motivated to participate in clinical trials, as they can benefit from new drugs and have access to best physicians and better healthcare
• Referral network developed
• High and rapid patient recruitment; 30-80% patients in international trials originate from CEE countries, mostly Poland and Russia
• Treatment nadve patients (oncology, diabetology, viral hepatitis)
• GCP standars incorporated into law
• EU Directive 2001/20/EC incorporated into law of Member States in this region
• Quality by FDA
  • Number of inspections in CEE countries 1994-2002: 23
  • NAI classification: 13
  • VAI classification: 10
  • OAI classification: 0 Source: FDA FOI web site
• Reasonable costs and investigators grant

We understand and fulfill your needs.

Let us improve your clinical research potential

There are many benefits of collaboration with CRDE :

• Broad expertise over CEE
• Experienced and educated staff
• Access to highly professional sites and regional great patient potential
• Experience in many therapeutic areas
• Highest quality, reasonable cost
• Flexibility and Complexity of service
• We manage clinical trials phase I-IV from single studies, country specific projects to complex international ones in a broad range of therapeutic areas thorough Central and Eastern Europe.
• Employees are professionals with life sciences degrees, MDs, DVMs, clinical trials know-how, all have undergone extensive training programs.
• Studies and their organization are in accordance to Polish law and ICH-GCP guidelines, EMEA and FDA standards.
• We operate according to our own SOPs or delivered by study sponsor.

Indication	Phase
Cardiology (hypertension)	III
Cardiology (hypertension)	II
Dermatology	IV
Diabetology (DM t2)	III
Diabetology (DM t2)	III
Nephrology	III
Nephrology	I
Surgery	III
Gynecology	IV
Gynecology	III
Rhematology (RA)	II
Rheumatology (RA)	III
Rheumatology (Coxarthrosis)	III
Oncology (Breast tumor)	II
Oncology (colorectal cancer)	III
Oncology (prostate tumor)	III
Opthalmology	III
Gastroenterology	III
Pulmonology (COPD)	III

• CLINICAL TRIAL PROJECT MANAGEMENT
• CLINICAL TRIAL MONITORING
• PHASE I, BIOAVAILABILITY, BIOEQUIVALENCE STUDIES
• DATA MANAGEMENT, EDC, BIOSTATISTICS
• MEDICAL WRITING (PROTOCOL, CRF, REPORTS)
• FEASIBILITY STUDIES
• QUALITY ASSURANCE
• REGULATORY HANDLING
• PMS STUDIES
• RESCUE STUDIES
• MEDICAL DEVICES
• EDUCATIONAL SERVICES

CLINICAL TRIALS MANAGEMENT
OUR SERVICES INCLUDE:

• Protocol generation and CRF design
• CRFs production
• eCRFs design and production
• Informed consent design and translations
• Sites feasibility, assessment and selection
• Regulatory and Ethics approvals
• Trainings for site personnel
• Investigator meetings
• Investigational product shipment and inventory
• Sites initiation
• Ongoing, routine monitoring
• Investigator grant administration
• Drug supplies handling
• Compliance management
• Patient recruitment support
• Managing CRAs network
• Project management
• EDC trials monitoring
• EDC trainings, consultancy and helpdesk

PHASE I UNIT

TYPE OF STUDIES:

• First administration
• Bioequivalence
• Bioavailability
• Drug - Food interaction
• Drug - Drug interaction
• Pharmacokinetics/pharmacodynamics
• Drug metabolism
• Safety and tolerability
• Dose finding

DATA MANAGEMENT
DATA MANAGEMENT SERVICES INCLUDE:

• CONSULTANCY
• CONVENTIONAL AND ELECTRONIC DATA MANAGEMENT INCULUDING CRF DESIGN AND MEDICAL CODING
• EDC SUPPORT
• FUNCTIONAL SUPPORT
• ORACLE CLINICAL & ORACLE THESAURUS MANAGEMENT SYSTEM
• TRAINING

MEDICAL WRITING

• PROTOCOL
• CASE REPORT FORM
  • e-CRF PREPARATION
• FINAL REPORT
• PATIENT DIARY

FEASIBILITY STUDIES

• CRDE helps to identify experienced investigators and right patient populations. We provide to our sponsor important data about:
  • recruitment challenges,
  • timelines,
  • budget.
• We provide feasibility studies through whole Europe

QUALITY ASSURANCE
CRDE quality assurance staff provides:

• In house System Audits for monitoring procedures
• On site audits, routine and for cause
• Compliance Management
• Site preparation to inspections
• Trainings for company and site staff on FDA inspection
• Training for CRAs
• Independent translators during FDA and EMEA inspection
• Consultancy on SOPs writing

PMS STUDIES
CRDE provides you with full service in PMS studies from study planning and design to final report:

• Planning and setup of study plan, simplified protocol and abbreviated CRF
• Sites selection
• Project management
• Data entry and validation
• Statistical analysis and reporting

The benefits for your company of PMS study conducted by CRDE are as follows:

• More data about safety profile of your product
• Increased awareness of your company product in medical practice
• Publications of study results in widely recognised journals

RESCUE STUDIES
CRDE takes over clinical trials all phases, that didn’t meet planned timelines due to:

• poor recruiment
• incorrect project management and monitoring
• bancrupcy of CRO
• other reasons

MEDICAL DEVICES
CRDE performs clinical trials of MEDICAL DEVICES:

• Trials are conducted according to:
  • local legal requirements
  • GCP standards
  • FDA guidelines
  • ISO requirements
• We help to obtain certification of CE sign

TRAININGS
Our trainings:

• Introduction to clinical trials monitoring for beginners
• Intermediate clinical trials monitoring
• Project management in clinical research
• GCP for investigators
• Bioequivalence and bioavailability studies
• Clinical trial audits and inspections
• Negotiation skills for CRAs
• Presentation skills
• Clinical trial design
• Polish, European and USA regulatory requirements in clinical research and other

• Adamed
• Amgen
• Aventis
• Bayer
• Beaufour Ipsen
• BIOMED Lublin
• Boehringer Ingelheim
• Bonne Sante
• CRC Development
• CROM
• CRO Poland
• ELI LILLY Polska
• Fresenius Kabi Polska
• Imform Polska
• Janssen-Cilag Polska
• Clinical Research Consulting
• KENDLE Branches
• Lundbeck Poland
• MDS Pharma Services Poland
• MSD Polska
• NMCT Poland
• Novartis Poland
• Novo Nordisk
• Organon Polska
• Pfizer Polska
• PHARMANET
• Pierre Fabre
• Pol-Nil
• Polfa Tarchomin
• Polfa Warszawa
• PRA
• Quantum Satis
• Sanofi Synthelabo
• Schering AG
• Scope International Poland
• STATMED
• Wyeth

Marek Kiersznowski
General Manager
Marek.Kiersznowski@crde.com

Roman Puchala
Business Development Manager
Roman.Puchala@crde.com

Contact Information

CRDE Sp. J.
Marek Kiersznowski, General Manager
ul. Srebrna 16
Warszawa 00-810 Poland
Phone: +48 22 620 26 62
Fax: +48 22 629 07 95
E-mail:

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