Clinical Trial Management
Goodwill Research is an integrated service provider for
pharmaceutical companies. We offer a complete clinical trial management
portfolio, from design, through investigator/study site selection, project
management, regulatory affairs, monitoring to final study reporting.
In the past years we organised numerous studies, we have been working
together with hundreds of investigators from academic medical centres,
hospitals, private practices and SMOs. Now we have the experience to advise our
Sponsors in assessing the appropriate investigational sites and in providing
the appropriate rate of subject recruitment. We manage study-related
contracting and financial matters on demand.
Our activities conform to ICH GCP principles, to pertinent Hungarian and EU
legislation, and we guarantee clinical trials to be performed according to the
protocol and pertaining regulations.
Core competencies
- Project management
- Regulatory affairs; communication with Central Ethics
Committee / Institutional Review Boards
- Study site and investigator selection
- Contracting and invoicing
- Study-related training, GCP training
- Monitoring (from feasibility assessment to study
close-out, serious adverse event reporting to the sponsor/regulatory
authorities, etc.)
Clinical research associates and assistants (CRA/CTA)
- Professional background: degree in nature sciences,
reliable spoken and written English skills, computer user skills.
- 3 to 8 years experience in clinical trial management.
- Continous education: SOPs, ICH GCP
Therapeutic areas of expertise
- Bronchial asthma
- Dermatology
- Gastroenterology
- Infectology
- Oncology
- Osteoporosis
- Rheumatology
- Stress
urinary incontinence
SOP system (Standard Operating Procedures)
- In-house developed SOP system available.
- We are ready to perfom tasks according to Sponsor SOPs.