CROs, CDMOs & commercial testing labs

From quote to invoice, with every client kept separate

HDLIMS runs the commercial and scientific sides of a contract lab together, from quote and sample receipt through testing, study reports and invoicing, while keeping every sponsor’s data segregated and every SLA in view.

The challenge

The challenges we hear most

01

Quotes and invoices live outside the lab

Pricing sits in spreadsheets and billing in accounting software, so tests added mid-project slip through unbilled and quoted scope drifts from what was actually run.

02

Clients want status, not emails

Sponsors and customers expect to see sample status and results as they happen. Without a portal, project managers spend their day answering status requests.

03

Segregation is a sponsor requirement

Sponsor audits check that one client can never see another’s samples, methods or results. Folder permissions and shared spreadsheets don’t hold up.

04

Mixed regulatory regimes

GLP studies, GMP release testing and ISO/IEC 17025 commercial work often share instruments and staff, each with its own documentation rules.

Capabilities

How HDLIMS supports Contract Testing Labs

Preconfigured workflows, terminology and reports for your industry, on the same unified platform.

Client portal

Clients submit requests, print chain-of-custody forms, track status and download approved reports and CoAs, seeing only their own projects.

Quotes to invoices

Price lists, client-specific rates and quotes convert into projects, and completed work flows to invoicing, including rush surcharges and add-on tests.

Study and project management

GLP studies with protocols, amendments, study directors and phases, alongside GMP and commercial projects with their own milestones and deliverables.

Multi-client data segregation

Client-level partitioning and access controls keep each sponsor’s samples, methods and results isolated, with audit trails to demonstrate it.

TAT and SLA tracking

Due dates are set from receipt and the agreed service level, and dashboards flag work at risk so planners can rebalance benches and instruments.

Client-specific reporting

Report and CoA templates per client and per study, with QA review and electronic signatures before anything is released to the portal.

Workflow

From quote to invoice

  1. 1

    Quote

    A quote built from your price list becomes a project with agreed tests, TAT and pricing once the client accepts.

  2. 2

    Receive

    Samples arrive against the project, are checked in with condition and chain of custody, and get a due date.

  3. 3

    Test

    Work is scheduled by due date under the GLP, GMP or ISO/IEC 17025 rules the project requires.

  4. 4

    Report

    Results are reviewed, signed and published to the client portal in the client’s report format.

  5. 5

    Invoice

    Completed work, rush surcharges and add-on tests flow to invoicing or your accounting system.

Regulations & standards

Designed to support your compliance program

HDLIMS provides the technical controls and records these frameworks call for. Compliance remains a property of how your lab configures and operates the system, and our validation package helps you demonstrate it.

ISO/IEC 17025:2017 21 CFR Part 58 OECD GLP 21 CFR Part 11 21 CFR Part 211 EU GMP Annex 11 ICH Q2(R2)
How HDLIMS supports compliance

Recommended modules

The modules Contract Testing Labs teams use most

FAQ

Contract Testing Labs: frequently asked questions

How does HDLIMS keep client data separate?
Every sample, project, method variant and result belongs to a client, and access rules apply across screens, reports, exports and the API, not just the user interface. Portal users see only their own work, and staff access can be restricted by client where a sponsor requires it. See Security.
Can HDLIMS support GLP studies?
Yes. Study records cover the protocol and amendments, study director, test and reference items, specimens and raw data, with quality assurance unit inspections and audit trails designed to support 21 CFR Part 58 and OECD GLP. See Compliance.
Does HDLIMS handle quoting and invoicing?
Yes. Price lists, client-specific rates and quotes are managed in HDLIMS, accepted quotes become projects, and completed work generates invoice lines that can be issued from HDLIMS or sent to your accounting system. See Integrations.
Can clients submit samples and see results online?
Yes. The client portal lets customers submit sample requests, print chain-of-custody forms and labels, follow status as work progresses, and download approved reports, CoAs and invoices. Each client sees only their own projects.

See HDLIMS configured for Contract Testing Labs

Book a tailored demo with a lab informatics specialist. We map your sample types, methods and compliance requirements, then show you exactly how HDLIMS fits.