Skip to content
Nexus Medical Group

Quality, ethics and confidentiality

Trust is built on processes

Our procedures are aligned with international Good Clinical Practice standards and with the regulations of each country where we operate.

Principles

Ethics first

No study begins without approval from an ethics committee or IRB and from the corresponding health authority.

Informed consent

Every participant receives complete information and decides freely, in accordance with the Declaration of Helsinki.

Quality by design

Risk management, standardized procedures and internal controls, in line with ICH E6(R3).

Data integrity

Traceable, auditable electronic records with access controls.

Reference regulatory framework

We work to the standards required by each health authority:

International

  • ICH E6(R3) — Good Clinical Practice
  • Declaration of Helsinki

United States

  • FDA — 21 CFR Parts 50, 56, 312 and 11
  • HIPAA — health information privacy

Mexico

  • COFEPRIS
  • NOM-012-SSA3-2012
  • Federal Law on the Protection of Personal Data (LFPDPPP)

Colombia

  • INVIMA
  • Resolutions 2378 of 2008 and 8430 of 1993
  • Ley 1581 of 2012 on data protection

Ecuador

  • ARCSA
  • Human Research Ethics Committees (CEISH)
  • Organic Law on the Protection of Personal Data (LOPDP)

Spain / European Union

  • Regulation (EU) 536/2014
  • General Data Protection Regulation (GDPR)

Confidentiality

Sponsor protection

We sign confidentiality agreements before receiving any information about the protocol or the investigational product. We never disclose molecule or sponsor names.

Participant privacy

Participant data are coded and pseudonymized. Only authorized personnel have access to identifiable information.

Restricted access

Information for each study is shared only with the team that needs it, with access controls and audit trails.

Social responsibility

We believe clinical research should reflect the communities it serves. That is why we bring studies closer to Hispanic and underrepresented populations, communicate in each participant's language and promote education about clinical research in our communities.