Core Competencies
ICH-GCP (ICH E6)ICH-GCP defines the harmonised (USA, Japan, EU) quality standard for clinical trials. The ICH requirements for clinical trials are taken as a basis for any quality management system around clinical trials. Clinrex can help in any matter around ICH-GCP, be it training, consulting, writing/reviewing SOPs or actually taking over certain tasks around clinical trials.
EU Clinical Trials Directive (2001/20/EC)
The EU Clinical Trials Directive aims for the approximation of the laws and regulations in the 27 EU Member States (MS) regarding GCP for medicinal products (drugs). By the implementation of the Directive in the MS (which is a must), simplification and harmonisation of the administrative provisions should have been achieved. On the other hand, new and more demanding provisions have been introduced, be it related to submissions to ethics committees or regulatory authorities or be it around SUSAR reporting. Furthermore, the sponsor has to have a legal representation within the EU (or European Economic Area, EEA).
Clinrex can be of help for any matters related to the EU Clinical Trials Directive. This might be of special interest for sponsors not maintaining any legal entity in the EU/EEA.
German Medicinal Product Act (Drug Law) and GCP Ordinance
The new legislation after the implementation of the EU Clinical Trials Directive represent a challenge for everybody who wants to conduct a clinical trial in Germany. Dagmar Chase's solid knowledge of the new rules and regulations and good contacts deriving from more than 25 years of experience in clinical trials in Germany can be of benefit for any sponsor/CRO who plans to start a clinical trial in Germany.
Review / Building of QM Systems / SOPs
External review of existing quality management systems / SOPs makes a lot of sense in order to identify procedural or regulatory weaknesses and/or unnecessary complexity which might have accumulated over the years. For start-up companies, the building of the system might be the focus. What do I need as a sponsor when starting a drug development?
Clinrex can help in identifying necessary changes, evaluating / (re-)writing SOPs and give advice regarding the streamlining of processes across (multinational) sponsor organisations.
Investigator Initiated Trials
Investigator Initiated Trials (IIT) are subject of the EU Clinical Trials Directive and are explicitly supported by the EU legislation. However, a lot of questions arise when an IIT should be planned. Who will support the clinical trial in order to reach full GCP compliance? What can industry contribute without becoming the sponsor itself? What about safety data? What kind of contract must be in place?
Clinrex can help IIT sponsors to ensure GCP compliance and can help IIT supporters to handle the IIT in the right way.
Project Coordination
Supervision of complex projects and making sure that sponsor expectations are met is one of the specialties of Dagmar Chase. Clinrex can be of help for sponsors by identifying the right partners in the EU and/or globally and can offer the role of the main contact point for a sponsor. This might be of special interest for sponsors outside the EU. To make sure that a clinical trial runs smoothly, i.e., the required quality standard is met and the study finishes on time and on budget are, and always have been, the genuine goals of Dagmar Chase's work in clinical drug development.
DSMB / DMC
DSMBs / DMCs have gained importance over the last years. One reason certainly is that the sponsor is fully responsible for a clinical trial and might have to decide on discontinuation of a clinical trial for safety or other reasons. A sponsor might be well advised to receive independent recommendations regarding critical decisions. Independent bodies need to be set up and managed. A well thought through data flow must be established which does not jeopardize independency of the DSMB/DMC members. In addition, complete documentation needs to be ensured for regulatory/ GCP purposes. Dagmar Chase serves as a facilitator on a number of boards and as such represents the interface between a sponsor company and the board. This way, the sponsor is not too close to the DSMB/DMC and board independency is demonstrated.
Training and Presentations
Ever since the start of her career, Dagmar Chase has been a trainer. She received an education in training skills and has held countless seminars and presentations during her professional life.
