Clinical Trial Directive
Refers to Directive 2001/20/EC which provides the approximation of the laws, regulations and administrative provisions of the European Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Clinical Trial Ordinance
Refers to the Swiss regulation “Ordinance on Clinical Trials in Human Research” (810.305) defining the requirements for the conduct of clinical trials in Switzerland.
Contract research organisation (CRO), a company that provides support to the pharmaceutical, biotechnology, and medical device industries for preclinical or clinical research services outsourced on a contract basis.
A Data Representative acts as your point of contact whom the EU or relevant GDPR supervisory authorities can contact for any issue related to your data processing. A data representative is mandatory for non-EU companies operating in the EU Article 27 (pg 48).
European Economic Area (EEA)
The EEA includes the 27 EU countries and also Iceland, Liechtenstein and Norway.
European Medicines Agency (EMA)
European Medicines Agency (EMA) is the agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products.
General Data Protection Regulation (GDPR)
The GDPR is a European regulation (EU 2016/679) on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
The goal of governance is to create a partnership where sponsors and CROs strive to share responsibility in clinical development. Milestones and KPIs (link) are shared on a regular basis, ensuring there is consistent communication with each vendor.
Is the international guideline established by the International Council of Harmonisation (ICH) on Good Clinical Practice (GCP) describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials, and incorporates addenda on the Essential Documents and on the Investigator’s Brochure.
Key Performance Indicators (KPIs)
A Key Performance Indicator is a measurable value that demonstrates how effectively a company/project is achieving key business objectives. Organisations use KPIs at multiple levels to evaluate their success at reaching targets.
Refers to EU Clinical Trial Directive 2001/20/EC Art. 19 (pg 17). A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA. Sponsors that are established outside the EU require a legal representative in the EU.
Oversight management ensures a project is completed according to plan e.g. within budget and timeframe, idealy using tools for performance measurement like KPIs (link to Key Performance Indicator)
Quality management is a system to manage all activities and tasks needed to maintain the desired level of excellence. The sponsor should implement a system to manage quality throughout all stages of the trial process.
Small and Medium-Sized Enterprise (SME)
Small and medium-sized enterprises (SMEs) are defined in the EU recommendation 2003/361. The main factors determining whether an enterprise is an SME are: staff headcount; either turnover or balance sheet total and Company category.