We provide full-service to support you through all the phases of medical device development in the changing legislative environment.  The cooperation of three experienced companies – Pharma-Regist, DRC LLC and Adware Research – with a stable presence for more than 20 years on the Hungarian market, guarantees a quality service from establishing and implementing a quality management system, through device consultancy and completion of clinical trials, to post-market vigilance

Strategy – service to market access

Design and implementation of a Quality Management System tailored to strategic objectives

Quality Management System maintenance

Internal audit

Pre-qualification audit, supporting the ISO certification procedure – per request

Device Classification

Communication with the Notified Body

Clinical evaluation, clinical trial

Consultation, preparation of clinical trials

Professional consultation about needs and possibilities

Investigational plan design 

Clinical database, sample size determination

Regulatory Affairs

Consultation on demand with the Regulatory Authority regarding submissions

Technical documentation, study documentation preparation and submission

Communication with the Regulatory Authorities

Clinical Evaluation Report

Local Project Management

Dedicated project manager in contact with our partners and Regulatory Authorities

Coordinating the team of professionals in each project

Contract management with sponsors, investigators and institutions

Supporting CRA’s performance and monitor visits

Clinical trial

Professional consultation about needs and possibilities

Investigational plan design 

Possible site selection and communication with sites

Preparation and management of the study protocol (English/Hungarian), Informed Consent Forms and participant Information Sheets according to Hungarian standards

Hungarian protocol summary preparation

Preparation and management of the documents of the trial application submission to the Hungarian Regulatory Authority and Central Ethics Committee

Amendment management, submission

Documentation, submission and follow-up of Adverse Events

Preparation and submission of Periodic Safety Update Reports and Amendments if needed

Submission of End of Study and trial outcome reports

Patients’ insurance management

Data management and biostatistics services according to regulatory requirements, and international guidelines

Electronic web-based data management system with monitoring function

Clinical database preparation, management

Biostatistical evaluation, data mining, statistical report writing

Accredited Phase I Unit

Several clinical sites available country-wide for multi-center studies

Clinical pharmacologists with various specializations

Qualified staff, laboratory

Outpatient clinics

Recruitment of trial population via healthy volunteer and patient database

Vigilance

Local contact to the Regulatory Authority Pharmacovigilance Department

Surveillance, submission of PSURs, line listings and local SUSARs 

Literature monitoring

24 hours availability