Services

Based on our professional approach, Associated Medical offers a proficient set of services that meets the clients’ needs and budget. Our services are tailored to guarantee visible results. Rigorous adherence to all standards, i.e. EMA regulations, ICH-GCP, our own and/or Sponsor’s SOP and local regulations is self-evident and leads to measurable outcomes. Our knowledge and expertise lead to an optimized strategy to gain most out of our common efforts.

We cover all phases of your study, starting from Phase I to III providing the following services in Poland and other countries.

Feasibility

Let us investigate the chances of your study. We will analyze our previous studies, verify our investigator database, contact the key opinion leaders and specialists to investigate how many centres, with how many patients and how quickly may fill up your study to turn it into success; by performing the feasibility for you we can help you in adjusting your study to the local requirements so that it would be more successful.

Vendor selection

We can provide you with a wide array of companies (EDC, Labs, IXRS) we have already worked with that can contribute to your clinical project. The burden of their selection, contract negotiation, signing and invoicing can be put on Associated Medical and make your life easier.

Patient recruitment Support

We provide our own patient recruitment approach which accelerates the patient recruitment tempo.

Regulatory affairs

The rumour says that submiting documents of a study in Poland is a challenge. We know how to do it and do it in an excellent way! Our vast experience, own registration strategies and up-to-date local knowledge result in a professional approach to document submission ending up in a positive decision to your trial.

Project management

We guarantee to provide in a timely manner all deliverables at every step of the project (initiation, planning, executing, monitoring and controlling, analysis and reporting) owing to our well structured organization of project management. Sensible risk assessment, tailored quality assurance management systems and sensible approach to all challenges are our essentials to optimize trial potential and provide reliable evidence.

Site management

We will identify, qualify and select the right sites for you (we will make use of our constantly growing investigator and centre database where all sites we provide meet our strict inclusion criteria and fulfill all requirement standards) and negotiate good site contracts and budgets within your schedule; additionally we will support you with a back-up sites in case of any disruptive event. Our study related team offers continuous support to the site staff and provides them with regular study controls and updates to guarantee proper and scheduled study conduct.

Clinical monitoring

We will take all steps to make sure that patients’ health during a clinical trial is the highest priority. By the regular visits and strictly specified communication strategies we will make sure that the work of the site staff meets regulatory and protocol requirements, study conduct issues, supervisory concerns, and data management matters.

Quality assurance

We always take care for the highest quality in your trial (i.e. Protocol/CRF Review, Trial Master File Audit, Investigator Site Audit, Clinical Study Report Audit). All the undertaken procedures are verified to be adhered to ICH-GCP and SOP regulations. Our compliance to the Internal Quality System is verified yearly by the external auditor who controls the quality at each step of a clinical trial.

Investigator meeting preparation

We have organized many multinational investigator meetings for our clients. Starting from the invitations, ending at the thank you letters we will make your meeting a fruitful and unforgettable event.


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Should you have any questions, please contact us: + 48 32 706 97 00 office@associated-medical-no-spam.com.pl