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CROs Legal Advice 1 Compliance

Supporting CROs with compliance and the legal security of their activities

AUMANS AVOCATS regularly advises Contract Research Organizations (CROs) on the legal and regulatory security of their activities, either as legal counsel or as an external Data Protection Officer (DPO).

This regular practice provides the firm with in-depth knowledge of CRO activities and processes, their relationships with sponsors, investigational sites, healthcare professionals, processors and partners, as well as the operational constraints associated with conducting research and clinical trials.

The firm advises both on specific projects or issues and as part of the ongoing support of CRO teams, particularly in relation to data protection, contracts, governance, risk management and incident response.

This knowledge of CRO activities enables AUMANS AVOCATS to provide legal support directly tailored to their practices, organisation and operational constraints.

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Dedicated expertise in CRO activities

CROs operate at the heart of a complex legal and regulatory environment, involving in particular the regulations governing research and clinical trials, the GDPR, the French Data Protection Act and the standards and Reference Methodologies issued by the CNIL.

The often international nature of research also requires CROs to take into account the regulations applicable in several jurisdictions and to establish an appropriate framework for international data transfers.

AUMANS AVOCATS supports CROs at all stages of their activities, including in order to:

  • determine the legal framework applicable to processing activities carried out in connection with research and clinical trials;

  • qualify the respective roles and responsibilities of CROs, sponsors, investigational sites and other stakeholders;

  • assess the compliance of research projects with the CNIL Reference Methodologies;

  • assist with the preparation and review of compliance procedures and documentation;

  • conduct or review Data Protection Impact Assessments (DPIAs);

  • establish an appropriate framework for providing information to patients and research participants;

  • analyse the conditions governing access to, use, sharing and reuse of data;

  • establish an appropriate framework for international data transfers;

  • assist in dealings with sponsors, partners and competent authorities.

External DPO services for CROs

AUMANS AVOCATS acts as an external Data Protection Officer (DPO) for CROs.

This role enables the firm to become part of the CRO’s governance framework and provide ongoing support to its teams, taking into account its organisation, internal procedures, clients and projects.

In this capacity, the firm assists in particular with:

  • performing the DPO tasks provided for under the GDPR;

  • advising management and operational teams on data protection issues;

  • maintaining or supervising the record of processing activities;

  • conducting and reviewing DPIAs;

  • supporting the implementation and development of internal policies and procedures;

  • becoming involved at an early stage in new projects in accordance with the principle of data protection by design;

  • assisting with data subject rights requests;

  • monitoring relationships with processors and partners;

  • raising awareness and providing training to teams;

  • assisting in dealings with the CNIL and other data protection authorities;

  • providing legal and regulatory monitoring tailored to the CRO’s activities.

Acting as an external DPO ensures continuity in compliance monitoring, while providing teams with a point of contact who is familiar with their activities and processes.

Contracts, responsibilities and relationships with partners

Contracts play a central role in CRO activities.

Agreements entered into with sponsors, investigational sites, healthcare institutions, service providers and other partners must clearly define the respective roles and responsibilities of each party and the conditions under which data may be processed, accessed, shared or transferred.

AUMANS AVOCATS assists CROs with the drafting, review and negotiation of, in particular:

  • agreements between sponsors and CROs;

  • agreements with investigational sites and other research stakeholders;

  • agreements with processors and service providers;

  • Data Processing Agreements (DPAs);

  • Joint Controllership Agreements;

  • Data Transfer Agreements (DTAs);

  • Data Access Agreements (DAAs);

  • Material Transfer Agreements (MTAs);

  • data protection and security clauses;

  • clauses governing international data transfers.

The firm also assists its clients with the qualification of roles and the negotiation of the allocation of responsibilities, particularly where the respective positions of the sponsor, CRO and other stakeholders must be assessed in light of the operations actually performed.

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Personal data breaches and incident management

Given the nature of the data processed and the number of stakeholders involved in research, the management of security incidents and personal data breaches is an important issue for CROs.

AUMANS AVOCATS assists its clients in managing such situations, in coordination with their internal teams and, where appropriate, their technical service providers and cybersecurity experts.

The firm assists in particular with:

  • analysing and qualifying the incident under the GDPR;

  • determining whether a personal data breach has occurred and assessing the related risks;

  • identifying the respective responsibilities and obligations of the CRO, sponsor and other stakeholders concerned;

  • organising the internal documentation of the incident;

  • determining whether notification to the CNIL or another data protection authority is required;

  • preparing and assisting with notifications to the competent authorities;

  • assessing whether data subjects must be informed;

  • assisting in communications with sponsors, clients, processors and partners;

  • participating in post-incident reviews and adapting internal procedures.

This approach combines operational responsiveness, legal analysis and regulatory risk management.

Audits, client questionnaires and processor compliance

CROs are regularly subject to audits or requests for information from their clients, particularly regarding their data protection, security and governance practices.

AUMANS AVOCATS assists CROs in preparing for and managing these processes, including in order to:

  • prepare for audits conducted by sponsors and clients;

  • respond to compliance and data protection questionnaires;

  • review documentation provided to clients and partners;

  • assist with the implementation of corrective measures identified following audits;

  • audit service providers and processors involved in processing activities;

  • define and implement procedures for selecting and monitoring processors;

  • document compliance and the governance of relationships with partners.

Governance and ongoing support for CROs

Beyond specific issues, AUMANS AVOCATS assists CROs with the long-term structuring and management of their compliance programmes.

The firm’s knowledge of CRO activities and processes enables it to work directly with legal departments, DPOs, senior management, clinical, quality, Data, IT and security teams.

The firm assists its clients in particular with:

  • structuring data protection governance;

  • integrating regulatory requirements into operational processes;

  • supporting the creation or development of new activities and services;

  • assessing new tools and digital solutions used in connection with research;

  • supporting the use of artificial intelligence solutions;

  • anticipating developments in European regulation and their consequences for CRO activities;

  • defining and updating internal policies, procedures and standards;

  • training and raising awareness among teams;

  • supporting international projects and issues involving multiple jurisdictions.

An operational approach tailored to CROs

AUMANS AVOCATS favours an approach that is directly integrated into CRO activities and processes.

Our knowledge of how CROs operate enables us to assess legal issues within their operational context and provide solutions that take into account regulatory requirements, contractual commitments, sponsor expectations and the specific constraints associated with conducting research.

The firm therefore acts both as legal counsel on specific projects and as an external DPO and long-term legal partner, helping CROs secure their activities and supporting their development.

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