Bridge Consult Medical




Bridge Consult Medical is your foundation in Eastern and Western Europe which will enable you to achieve your goals of

  • Clinical evaluation
  • Legal compliance
  • Reimbursement
  • Market introduction


Our Vision is

A cooperative environment of medical industry, regulatory authorities, and medical professionals across Europe. We all have the ultimate goal of advanced, effective, and safe medical capabilities to better care for our corner of the world.



Our Mission is

To bring technology, research, and capabilities to the medical communities we serve. You strive to develop, physicians strive to explore, we will bring you both together.



Our Goal is

To be the eastern pillar of the bridge to Europe, to enable a cooperative environment of clinical research for the mutual benefit of medical development companies, investigators, and the medical community.



The opportunities are vast, and this is where we live.

About




Headquartered in Warsaw, Poland, with cooperating staff in Poland, Czech Republic, and Slovakia; our reach extends across Europe and into Russia. Experienced in clinical submissions and study management across Europe, we stand ready to be your cooperating partner for:

  • Investigator identification, recruitment, and communication
  • Legal and Regulatory strategy
    • Study submission and communication
    • Data transfer authorization
    • EU representation
  • Study staffing and management
  • Trial master file
  • Database development and management
  • Reimbursement strategy and submission


Long distance relationships are complex. You will feel we are in the adjacent office.

Why Bridge Consult




The mission and strategy of Bridge Consult Medical [BCM] is to bring technology, research, and capabilities to the medical community we serve.

The operations of BCM are based strongly on our relationships with professionals across Europe.

This network includes physicians, reimbursement specialists, and clinical research professionals. The physicians we communicate with include Key Opinion Leaders (KOLs) as well as Country Consultants – Government appointed Professors/KOLs.

We come from a wide background within medical technology.

People actively involved in our operations include MDs and engineers experienced in medical device product development, program management, and submission. The clinical and technological experience of Bridge Consult members includes Anesthesiology, Cardiology, General Surgery, Pharmacology, and Urology.

We are continuously developing our activities and knowledge base.

We work to strengthen our involvement in Urology and to build on our network of Cardiologists, Orthopedics, Wound Care, and Diabetes Specialists. We are always ready to offer clinical support to companies we represent and explore new applications of products and technologies.

Based in Warsaw, Poland, with a warehouse facility in Łomianki (just north of Warsaw), we have shipping and receiving personnel available around the clock.

Our capabilities include:


  • Clinical Study Management
  • Regulatory Support
  • Legal EU Representation
  • Documentation and Records Management
  • Data Management
  • CE Marking and Commercialization Support


Your success is our success. Please consider Bridge Consult Medical to be part of your organization.

Services


With our network of physicians, we are two phone calls away from any physician in Poland, three from any in the rest of the EU

Trial Management

  • Center Selection Through Start Up
  • Site Management and Communication
  • Monitoring: On Site and Remote
  • Product Accountability
  • Procedural Support

Data Management

  • Data Collection and Entry
  • Data and File Management
  • Secure File Server
  • Study Document tracking and Revision Control
  • Database development and support

CE Marking and Commercialization Support

  • Notified Body Communication and Planning
  • Commercialization Support
  • Reimbursement
  • Product Registration
  • User Communication and Recruitment

Trial Material and Records

  • Study design
  • Protocol and Informed Consent Development
  • Site Selection and Qualification
  • Trial Master File Management
  • Study Report Development
  • Publication Management

Regulatory Support
Legal EU Representation

  • Regulatory Submission and Communication
  • Ethics Committee Tracking and Communication
  • CA Audit Support
  • EU Representation
  • AE Reporting and Follow-up

Contact Us


E-mail:

info@bridgeconsult.com.pl


Fax:

(+48) 22-486-9029

* required.