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The clinical development process requires expertise and skills to be available when you need them.
If your staff is not readily available for the tasks you need completted at the short notice, please contact us. |
ICH GCP TRAINING
Introduction to GCP
Contact: 
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Dec 3rd 12:45 – 16:45
This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the Regulatory Authorities will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies. 
ICH GCP workshop
Contact: 
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Dec 3rd 08:15 – 12:15
This workshop is intended for Clinical, Regulatory, and Quality Assurance Personnel who need to be familiar with Good Clinical Practice (GCP) and FDA regulations and requirements. The workshop will be conducted to review FDA GCP regulations, recognize how GCP impacts the clinical research process, confirm how to prepare concise documents and provide necessary information for the clinical studies and to maintain an ongoing relationship with the FDA - with actual examples, work in groups and questions and answers (Q&A) sessions.
GCP for Investigators
Contact:
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Dec 10th 12:45 – 17:00
This course is intended for Investigators who need comprehensive review of Good Clinical Practice (GCP) and FDA regulations from the site perspective. This course covers in depth Investigator responsibilities. The course will also benefit other site personnel who must be familiar with the essentials of the clinical process and requirements.
ICH GCP Refresher Course
Contact:
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Dec 10th 08:15 – 12:15
This course is intended for Clinical, Regulatory, and Quality Assurance Personnel who require an annual commercial refresher course of the GCP regulations and requirements. This course will also benefit other personnel who must be familiar with the essentials of the clinical process and requirements.
IATA DANGEROUS GOODS TRAINING
IATA Dangerous Goods Regulations for Clinical Site Staff
Contact:
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Oct 15th 12:15 – 14:45
The course is intended for Clinical Site staff who will work with laboratory sample packing, handling and shipping via air courier, if the IATA (International Air Transport Association) consider these packages "dangerous goods" (esp. infectious substances – class 6.2 and dry ice-class 9) This course covers essentials for shipment classification, packing, marking, labeling, required documentation for shipping biopharmaceutical Dangerous Goods and changes to current IATA regulations.
Written Test, IATA Dangerous Goods Regulations
Contact:
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Oct 15th 11:00 – 12:00
For those who have taken IATA Dangerous Goods Regulation course previously, but need to pass annual written test.
INVESTIGATIONAL SITE MOTIVATION TRAINING
Enrollment Solutions, Investigational Site Motivation training
Contact: 
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Oct 22nd 8:30 – 16:45
This course provides a comprehensive review of the main reasons why Investigational Sites fail to enroll subjects in the Clinical Study. Participants receive a foundation of knowledge about how to identify those reasons and how to guide the Site Staff to overcome them to turn a non-enrolling site into a motivated enroller. Guidelines for design of Site-specific enrollment plan and tools are provided; techniques are discusses for Investigator persuasion to aid Site Staff prioritizing the Study tasks over non-study obligations. Information on maintaining an ongoing relationship with the Site will also be discussed. This course enables Clinical Research Associates (CRAs) and Site Monitors to end non-enrollment at the Investigational Sites.
Enrollment Solutions, Investigational Site Motivation training
Contact:
Address: 7 Peldu Street, Jelgava LV-3002, Latvia
Nov 26th 8:30 – 16:45
This course provides a comprehensive review of the main reasons why Investigational Sites fail to enroll subjects in the Clinical Study. Participants receive a foundation of knowledge about how to identify those reasons and how to guide the Site Staff to overcome them to turn a non-enrolling site into a motivated enroller. Guidelines for design of Site-specific enrollment plan and tools are provided; techniques are discusses for Investigator persuasion to aid Site Staff prioritizing the Study tasks over non-study obligations. Information on maintaining an ongoing relationship with the Site will also be discussed. This course enables Clinical Research Associates (CRAs) and Site Monitors to end non-enrollment at the Investigational Sites.