Businessmen

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.

 
AdobeStock_59162630.jpeg

OUR MOTTO:

Higher Quality - Healthier Patients

Parkinson.jpeg
 
 

OUR MANAGEMENT TEAM

Head of CROS CRO Clinical Operation Services and  Business Development. Involved in all levels of clinical operations. Started in clinical site Oncology Hospital, then worked at top international pharma companies at the global structure and finally at international CROs leading a global team of clinical operations professionals.

Spent 15 years in the United States where graduated from Forest Hills High School, NY, Bergen Community College NJ, and hold various positions before moving to Poland. Holds a Master’s degree in science from Rutgers University in Newark, NJ

Magdalena Siekacz

Head of Clinical Operations

BD and Project Manager responsible for Projects Management and clinical conduct of the studies.

Graduated from Biotechnology, Medical Analytics, Quality Management, and Project Management.

Started professional career as Laboratory Diagnostician in Microbiological Department of Medical Laboratories.

Several years of experience in clinical operations as well as management of early phases clinical trials site. Responsible for start-ups, supervision of study conduct and business development activities in previous companies.

Marta Marek

BD Manager, PM

QA/QC Manager in CROS CRO. Experienced in either early or late phases clinical trials. Started her professional career in this field in a clinical site as a Pharmacist and then as QA/QC Specialist.

Responsible for quality control and assurance of processes and documents.

Graduated from Pharmacy on Medical University in Warsaw. Participated in many courses related to clinical trials as well as quality management. Certified ISO Auditor.

Aleksandra Kania

QA/QC Manager

 

 

 

PR & Marketing Manager responsible for administrative and financial matters and scientific conferences organized by CROS. A man with numerous interests, including: electronics (Electronic Technical College in Warsaw), aviation (Warsaw University of Technology, MEL Faculty) but mainly a sports lover, especially handball (2018 Polish Masters 50+ Champion).

Donat Czujkowski 

PR & Marketing Manager

 

 

 

BD & Marketing Manager.

 

Started studying Molecular Biophysics at Warsaw University and now going through USWPS, specializing in Neurocognitive Science.

 

Involved in multiple grants and research teams. Co-author of articles about the genetic basis of empathy. Creative, open-minded, and always ready to help. 

Natalia Krakowska

BD & Marketing Manager

 

THERAPEUTIC AREAS

AdobeStock_214310161.jpeg

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

involve 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). 

 
PROJECT MANAGEMENT
  • Project set up and Delivery from Feasibility to Close out visit

  • Risk Management

  • Vendor Management

  • Project coordination

FEASIBILITY

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

OUTSOURCING

Outsourcing is also known as Business Process Outsourcing (BPO). This is the process of hiring another individual or company, to handle business activities for you.

Thanks to our long-term experience on the market and database of experienced specialists we can provide a business practice that allows small, medium, and large-sized organizations to gain the proper skills and competencies in a short period of time. It means, that “you can develop and grow your business any time you need and anyway you need without major investment”.

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 START-UP
  • 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

We ensure very close and efficient communication with site and Investigators, sites personal training on all study team levels, sites activation, pro active support of study team at the site, outsourcing CROS specialist to the Clinic for ensuring highest quality, Motivational visits at the sites, referral network.

 
 
 
 
 
 
 
 
 
 
 
 
 
  • Extensive contact database (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

Kobiety Holding Hands

OUR UNIQUENESS