Ongoing
Fractional CDM leadership
A named data management lead in your study team, at the fraction of a week the work actually takes. You get senior judgement in the room without a permanent hire.
Clinical data services · Zug, Switzerland
Data problems don't go away.
They get more expensive.
Preceda provides senior clinical data services — data management, database development and clinical programming — the expertise a study needs, without the headcount.
The situation
Most small sponsors don't have a data manager. They have a CRO, a clinical operations lead whose attention is rightly on sites, contracts and study start-up, and a database that hasn't been independently reviewed by anyone who builds them for a living.
The problems surface at UAT, at the first interim, or at database lock — by which point fixing them is more complicated, and costs many times what preventing them would have.
Preceda exists for that gap.
Services
How to engage
Preceda works across all therapeutic areas and on device studies. Most engagements begin with a call or an email: what you need help with, what you are looking for, and where Preceda can help.
End to end
Full-service data management
Protocol review, data management plan, CRF design and completion guidelines, database build and validation, edit check specification, UAT, ongoing data review, trial metrics and review listings, reconciliation and database lock — held outside the CRO.
Independent
CRO oversight
Review of the work being done on your behalf: an assessment of your CRO's data management quality, study build diagnostics, specification review, and the questions your CRO isn't expecting to be asked.
Fixed fee
Defined pieces of work
Discrete deliverables at a fixed scope and price, with no ongoing commitment. A protocol review before finalisation. Study metrics and review listings, set up once or produced each month. An independent review of your study build. Often the sensible way to start.
Capabilities
What clinical data services cover
The full scope, so you can find the specific thing you need. Aligned to ICH E6(R3), ICH-GCP and the SCDM Good Clinical Data Management Practices guidance.
- Protocol review for data collectability and internal consistency
- Data management plan
- Data acquisition planning across all sources
- EDC and vendor selection support
- Database build and validation
- eCRFs designed to CDISC standards
- eCRF completion guidelines
- Edit check specification and configuration
- UAT planning, scripts and execution
- Site training and investigator meeting support
- External data integration — labs, ePRO, imaging — with transfer specifications and reconciliation
- Data review for errors and trends, with query generation and resolution
- Sponsor data review plans
- Coding dictionary management and version upgrades
- SAE reconciliation
- Protocol deviation detection from the data, as an independent check on the clinical operations log
- Data quality management — quality plan, acceptance criteria, error-rate measurement
- Real-time trial metrics and review listings
- Data privacy and de-identification — GDPR, revised Swiss FADP
- Database lock, closure and archival
- CDISC-conformant deliverables — CDASH, SDTM
- ICH-GCP, ICH E6(R3) and 21 CFR Part 11 compliance
- CRO oversight and vendor governance
Systems are not a constraint. Preceda works in whichever EDC you have chosen — hands-on experience in Medidata Rave and Medrio, and metadata-driven methods that transfer across platforms. Regulatory context spans Swissmedic and HRA-ClinO, EU CTR, FDA and MHRA, and EU MDR with ISO 14155 for device studies.
Work samples
Outputs from real studies
Anonymised: participant identifiers replaced, study numbers removed. Shown so you can judge the work rather than take my word for it.
Earlier than usual
Data management normally sees the protocol last
By convention, the protocol reaches data management when it is final — to be built from, not commented on. Every problem found after that point costs an amendment.
A protocol review before finalisation asks a different question from the usual feasibility read: not whether the study can be run, but whether it can be collected. Whether the schedule of assessments has a data model. Whether visit windows are defined and reachable. Whether anything is scheduled after end of study.
It is a small piece of work, and the cheapest hour anyone spends on the study.
What you get back
A written review covering what can be built as written, what is internally inconsistent between the schedule of assessments and the body text, what breaks common study rules, and what will force an amendment once the database exists — with a short list of changes in priority order.
Start with a call or an email. A confidentiality agreement can be in place before any document changes hands.
What you inherit
A working quality system, not a blank page
Sponsors engaging Preceda don't pay for procedures to be written from scratch on their program's timeline. The library already exists, aligned to ICH E6(R3) and SCDM GCDMP, with matching templates for every procedure.
Alongside it: proprietary tooling for Medidata Rave and Medrio study build diagnostics, protocol-to-CRF specification, and metadata-driven data review — built over years of finding the same defects in other people's builds.
27
SOPs, GCDMP-aligned
14
Ready-to-use templates
29
Years in clinical data management
Where it matters
First-in-human is the moment
The transition from preclinical into the clinic is when a data management plan and CRF specification are needed and nobody internally owns them. Decisions made in those weeks — how endpoints are captured, which checks exist, what the CRO is accountable for — determine how much the rest of the study costs to clean.
It is also the cheapest point at which to fix any of it.
About
Sarah Huntley
Twenty-nine years in clinical data management, including director-level roles in biotech. The deepest experience is in oncology — early phase and complex designs among them — but the discipline is the same wherever the trial sits, across all therapeutic areas and device studies under MDR.
Oncology is where the data problems tend to be hardest. It is a good place to learn the work, not a limit on where it applies.
Preceda GmbH is a one-person consultancy by design. Engagements are delivered personally: there is no bench, no handover to a junior after the pitch, and no account manager between you and the person doing the work.
BSc Biology, Carnegie Mellon University. Certificate in Leadership and Management, UC Berkeley.
Standards & systems
CDISC — CDASH, SDTM, ADaM· ICH-GCP· ICH E6(R3)· SCDM GCDMP· Medidata Rave· Medrio· SAS· Python· Swissmedic / HRA-ClinO· EU CTR· EU MDR / ISO 14155
Working across the Swiss life sciences cluster from Zug, and with sponsors in Germany, the United Kingdom and the United States.
Get in touch
Planning a first-in-human study?
Or not certain your CRO's build will survive contact with real data? I'm glad to have a conversation — nothing to prepare, and I'm more useful once I understand the program.
sarah@preceda.ch
Preceda GmbH
Bahnhofstrasse 21
6300 Zug, Switzerland
Bahnhofstrasse 21
6300 Zug, Switzerland