Study support for sponsors and CROs
Clinical research support for sponsors and contract research organisations: data, programming, writing, submission documents, site feasibility, monitoring support, and the trial master file.
ForeMed supports defined clinical-research activities. We do not describe the company as the sponsor of a trial, as the investigator, or as a full-service CRO. Those roles exist only when a contract creates them.
Work follows your protocol, your templates, and your quality system. We can take one function — data management, or writing, or file management — without taking the study.
01
We support clinical data management across a study: CRF design, database build, data cleaning, medical coding of clinical data, and SAE reconciliation.
Supporting documents — a data management plan, edit-check specifications, data-entry guidelines, coding guidelines — are written to your templates when you include them. User acceptance of a database stays with the people you name.
02
We support statistical programming: datasets, tables, listings, and figures specified by your biostatistics lead, with a quality check against the specification.
We do not assume the role of accountable statistician. If you want that role from ForeMed, it has to be named in the contract. It is not implied by programming support.
03
We support medical writing for protocols, clinical study reports, and informed consent forms, using your template, your style guide, and your review cycle.
Writers work from the decisions and the data your clinical team provides. We do not invent endpoints, eligibility rules, or results.
04
We support compilation and publishing preparation for submissions you are already responsible for: document lists, formatting, and coordination of response documents.
We do not file as the sponsor, and we do not give a legal or regulatory opinion. The person who signs the submission remains the person your organisation names.
05
We support feasibility questionnaires, site identification against criteria you set, and start-up tracking.
Site contracts, budgets, and investigator payments stay with the party your study assigns. We do not select a site by promising enrolment.
06
We support monitoring under your monitoring plan: visit preparation, the source-data review you assign, and monitoring-visit reports.
This is support to a plan you own. It is not, by itself, a claim that ForeMed runs a full-service monitoring operation.
07
We support trial master file completeness checks, document indexing, and inspection-readiness housekeeping against your TMF plan.
A completeness check is not a certification of the file, and it is not an inspection result.
01
One or more of data management, programming, writing, submissions support, feasibility, monitoring support, or TMF. The protocol and the templates come first.
02
Specifications, review cycles, and who accepts a deliverable are written down. We do not start from a blank method of our own.
03
CRFs, cleaned data, programmed outputs, draft documents, tracking logs, or file updates — the artifact named in the specification.
04
Quality check against your plan, then a correction cycle. Sample size and acceptance rules are agreed per study. They are not copied from the coding audit rate.
Clinical research deliverables are checked against the specification you approved. The check is documented.
The 3–5% daily audit sample applies to coding and revenue-cycle production. Study work uses the sample and the acceptance rules in the study plan.
We do not describe a draft protocol, a programmed table, or a TMF check as a regulatory approval.
Yes. Data management, programming support, medical writing, submissions support, feasibility, monitoring support, and TMF management can each be scoped alone.
Not unless the contract says so. Programming support means we produce the outputs your biostatistics lead specifies and we check them against that specification.
Protocols, clinical study reports, and informed consent forms, to your templates. Other documents can be discussed if you have a template and a review cycle for them.
The services on this page are support to a sponsor or to a CRO. A full-service obligation exists only if a contract creates it. This page does not.
Other service lines
Next step
Name the setting, the volume, and which part of this page you want. We will scope from that, not from a standard package.