ABOUT US
CROS CRO was founded in 2017 by Magdalena & Adam Siekacz, in response to the Polish market demand for high-quality CRO services.
Since then we have conducted several clinical studies, including FIH, Phase I, II, III, and observational studies.
Our Team includes people with many years of experience in clinical studies, either in CRO or Clinical Sites. Due to our commitment and engagement in implemented projects, we are known as a reliable, flexible, and high-quality company. We care about our clients and provide tailored made services.
OUR MOTTO:
Higher Quality – Healthier Patients
OUR MANAGEMENT TEAM
Magdalena Siekacz
Head of Clinical Operations
Aleksandra Kania
QA/QC Manager
Donat Czujkowski
PR & Marketing Manager
Due to cooperation with scientists and specialists in different areas, we are able to offer clinical study management in various therapeutic areas.
Our offer covers a wide range of studies, which involves cardiovascular, dermatology, endocrinology, gastrointestinal, gynecology, hematology, immunology, infectious disease, nephrology, oncology, neurology, orthopedics, psychiatry, rheumatology, and urology studies.
We also manage studies with healthy volunteers, such as FIH, Ist phase, medical experiments, vaccines, or studies with special populations (elderly, rare diseases, smokers, etc).
CLINICAL RESEARCH ORGANIZATION SERVICES
PROJECT
MANAGEMENT
- Project set up and Delivery from Feasibility to Close out visit
- Risk Management
- Vendor Management
- Project coordination
Our methodology is focused on effectiveness measured by time to response, motivated number of sites, reliable assessment of potential recruitment population for the study. Local standards of care research.
Feasibility tools support the high-quality feasibility data by
- Selection of sites from our network led by very motivated and committed Investigators allows fast initiation of the trial, conduct, and closeout
- Approaching the best Investigators in the therapeutic area/field
- Saving time for a complete response to our Client
We provide three models of feasibility data requirements, which fit best in the specific clinical trial stage:
- Basing on the best specialists in our Network, we can give a quick, reliable, and brief review of the potential of sites to perform the study and estimate potential enrollment.
- Full-providing precise, solid data. CROS works very closely with clinical sites to identify issues, risks that might affect recruitment, execution, and or patient retention, and protocol areas that might affect study execution.
- High-level Feasibility- consultancy experience allows us to support and advise the Sponsor at the project design level. The following factors need to be analyzed:
- Population
- Recruitment potential
- Local standards of treatment
- Regional and or country-specific regulation influencing study registration and conduct, including the timelines
- Logistic conditions
MEDICAL
MONITORING
- Scientific support
- Medical Data Review
- Medical trainings
- Medical expertises
CLINICAL
MONITORING
- Pre-study, Initiation, Monitoring and Close Out Visits, we can outsource Specialist to perform clinical monitoring visits accordingly with Sponsor’s requirements
- Remote Monitoring Activities
- Risk-Based Monitoring
REGULATORY
AFFAIRES
- Clinical trial application for IMP and device studies
- RA and IEC IRB review and submission process
- Legal representation services
- Import and Export expertise
- Adequate all risk insurance
INVESTIGATOR
MEETINGS
- Investigator meetings are crucial in the area of clinical trials. It gives opportunities to discuss protocol, regulatory issues, procedures, and safety criteria together between the sponsor and the site team such as: principal investigators, coordinators, CRA’s, etc.
- Our aim is to promote the polish region on the international area. Clear logistic communication and innovative way of organizing this meetings will be the guarantee of the trial success.
- Sites contracting
- Sites personnel training
- Site activation
PATIENTS
RECRUITMENT
- Study sites coordination
- Site recruitment
- Retention Plans
QUALITY
ASSURANCE
- Site audits
- Co monitoring visits
- Audits of trial master files
- Process audits
- SOP writing and review
TRAININGS &
COMPLIANCE
- ICH GCP Investigator site personnel training
- Development programs for CRAs and CTAs
- Tailored educational solution for Sponsor
- Therapeutic Area Trainings
SITE MANAGEMENT
AND
COORDINATION
OUR UNIQUESS
Extensive contact (medical centers, doctors, patients) in Poland and abroad
Specialized research personnel (and Investigators), which enables us to provide a comprehensive service
Unique methodology
High business standards
Strong theoretical and practical background
