Who's doing what, under which contract.

Two Entities. Two Roles. No Blurred Lines.

MDTrials CRO and MDTrials Sites operate under one commercial brand but through separate legal entities. Either service line can be engaged independently. When both support the same study, responsibilities, contracts, data access, oversight and escalation arrangements are defined and disclosed rather than assumed from common ownership.

 

MDTrials combines CRO capability and site-network capability under one commercial brand, but it does not collapse the responsibilities of the two functions.

 

Sponsors should be able to see who is doing what, under which contract, and how oversight is protected when an affiliated site participates.

Structure and independence
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Legal-structure

MDTrials CRO services are provided by Conduct Research Inc. MDTrials Sites services are provided by Searich Enterprises Inc. These legal names are used for contracting, governance and other required attribution; the public-facing service lines remain MDTrials CRO and MDTrials Sites.

Encrypted data

Data-access safeguard

Common ownership does not create automatic access to sponsor, site or participant information across service lines. Personnel access is based on assigned study responsibilities, authorised systems and applicable contracts. Where both service lines participate, access and role boundaries are documented before study activity begins.

Training. Delegation. Coordination.

Corporate structure

  • MDTrials CRO services are provided by Conduct Research Inc.
  • MDTrials Sites services are provided by Searich Enterprises Inc.
  • The entities are under common ownership but remain separate legal operating companies
  • The applicable legal entity is identified in contracts, service documentation and relevant public disclosures

Study-level safeguards

  • Sponsor-delegated CRO work and investigator or site operational work are defined separately
  • No individual is assigned conflicting CRO-oversight and site-operations roles on the same study
  • Affiliated sites are assessed against documented study requirements and are not automatically selected
  • The affiliation is disclosed when both service lines participate
  • Monitoring and findings at affiliated sites follow the approved monitoring and escalation process
  • Audit and QA activities are assigned independently of the operational activity being assessed
  • Inter-company services are governed by documented arrangements rather than informal resource sharing
Outsider

Independent third-party oversight

Where a sponsor requires independent third-party monitoring or audit of an affiliated site, the arrangement can be defined in the study oversight model. MDTrials will cooperate with the access, documentation and follow-up required for that oversight.

Pros and cons

Why this matters

Health Canada can inspect CROs and SMOs involved in Canadian clinical trials, and ICH E6(R3) expects transferred responsibilities and service-provider oversight to be documented. The MDTrials structure is designed to make those responsibilities visible rather than blur them. [R19–R20]

Frequent Questions

  • How is independence maintained when the CRO and the sites are related?Through separate legal entities and contracts, separation of study-level roles so no individual holds both CRO oversight and site operations on the same study, independent assignment of audit and QA activity, disclosure whenever both service lines participate, and documented inter-company arrangements rather than informal resource sharing.
  • Who do we contract with?With the legal entity providing the service: Conduct Research Inc. for CRO services, Searich Enterprises Inc. for site services. Where both are engaged, the scope and liability of each are defined separately.
  • Can we require an independent monitor at your affiliated sites?Yes. The arrangement is defined in the study oversight model and MDTrials provides the access and documentation the independent party needs.
  • Will an affiliated site be selected automatically for our study?No. Affiliated sites are assessed against the same documented criteria as any other candidate, the relationship is disclosed when the site is proposed, and the selection decision is yours and is recorded.
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