According to Determina AIFA 809/2015, any clinical research Unit conducting Phase I trials in Italy is obliged to comply with a series of standards to obtain accreditation. These standards include:

  • Facilities: clinical facilities should be appropriately controlled and allow that study subjects to remain there for supervision during and after dosing as required by the protocol. All laboratories’ equipment and computerised systems should be validated according to the applicable regulation;
  • Staff: all units should have qualified staff for resuscitating and stabilising individuals in an acute emergency. Moreover, it is important that investigators and medical staff is trained appropriately. Their training should include not only relevant medical expertise but also knowledge of GCP;
  • Procedures: all units and laboratories should have written, authorised procedures and should update them in accordance with the last version and remove obsolete versions from circulation.

In seQure we offer a complete package of Quality Assurance services to guarantee compliance of Phase I Units and their laboratories with the requirements described in Determina AIFA n. 809/2015.

Our Phase I package includes

  • Assessment of the current Phase I Unit status
  • Gap analysis to evaluate missing requirements
  • Revision of the existing processes and their optimisation, creation of the missing one
  • Creation of necessary general SOPs, Clinical Unit SOPs, Laboratories SOPs
  • CSV
  • Support in the implementation of the new processes
  • GCP QA Manager – internal QA role
  • Qualified auditor according to Determina
  • Internal GCP training to Phase I stuff

Reach Phase I accreditation and the full operational compliance with Determina AIFA 809/2015 with seQure

Our approach

We at seQure have developed a lean model for obtaining Phase I accreditation and full operational compliance. The efficiency of the model is reached by the application of a Lean Methodology that allows achieving results faster by identifying value-creating steps and eliminating or reducing non-value-adding steps.

Preparation Phase:
Define and Measure

Assessment Conduct Phase:
Analyse

Final Evaluation, Action Plan and Assistance for Implementation Phase: Improve and Control

Why seQure?

Experience

Consolidated experience in supporting 10+ Phase I Units in obtaining the certification

Certified Auditors

Get access to the network of our certified experience auditors available to support you on your road to successful certification

Unique Lean Approach

Increase not only compliance but also efficiency. Benefit from the process improvement through eliminating the waste and adopting technology with our unique Lean approach

Power of Technology

Get access to the latest technology to streamline your QA processes thanks to seQure’s ISO 27001 certified partner Arithmos.

Ensure your Determina AIFA 809/2015 compliance