Research
We have experience in conducting above 150 studies of Phase II-IV clinical studies and medical device studies. We can support you in the whole or partial processes in clinical studies
NER Consulting develops concepts including protocol writing and case report form composition in collaboration with the therapeutical area experts upfront.
NER Consulting organizes Expanded Access Program (EAP) also known as “compassionate use program”. EAP is a way to make investigational new drugs available prior to
regulatory approval to patients with a serious or life threatening disease or condition who cannot participate in a clinical trial.
Feasibility is the primary success factor of patient recruitment in a clinical research. Site feasibility and selection with detailed reporting system and development of sites with training and infrastructural consultancy is provided upon request.
Clinical Research Staff Recruitment is organized in accordance to relavant human resources procedures. Trainings for junior staff are provided by ACRP (Association of Clinical Research Professionals) certified CRAs; trainings for senior staff are provided by ICF (International Coach Federation) certified coaches.
Standard Operating Procedures (SOPs) should be in place for all processes to be run by pharmaceutical companies or contract research organizations. SOP development, checklist, quality control and quality assurance systems are designed for clinical research related activities.
Audit is the second quality assurance step in a clinical, research project. Audit preparation consultancy and trainings on audit in clinical research projects are provided.
