Investigator-initiated and academic research

EDC for Investigator-Initiated and Academic Studies

A study-ready database for research teams with a grant, a protocol and no programming department: we build it, test it with you, host it and stay with you until the final dataset is delivered.

Investigator-initiated studies are often run by a principal investigator, a research nurse and a statistician with other commitments. Enterprise EDC platforms assume a data-management team, and free tools assume someone has time to learn and maintain them. ResearchGuru is a managed service between the two.

Discuss your study

Why a managed service

What a small study team gets

No programmer to hire

Our team does the eCRF programming, configuration, testing and technical support.

Nothing to install

The database is hosted securely and used in the browser. There is no software for your IT department to maintain.

Researchers on the other side

You work with epidemiologists and senior researchers who understand study design, not a ticket queue.

Days, not months

Straightforward studies can be configured within days once approved documents are received.

Controls an ethics committee expects

Named accounts, role-based access, an audit trail and scheduled backups.

A first look at the data

Built-in tables, figures and listings for data reviews and progress reports.

Your formats

Final data in Excel, CSV, R or Stata, with a CDISC export where needed.

Scope that fits the grant

Each study is quoted on its own scope, so you pay for what the protocol needs.

Studies we support

From a single-site pilot to a multi-site study

The database is configured to the design in your protocol. Site staff can enter the data, participants can report it themselves, or the study can combine both.

If the study grows, sites, users and languages are added to the same project, and amendments go through change control so that earlier data stay comparable.

Typical designs

  • Pilot and feasibility studies
  • Randomised studies
  • Cohort and case-control studies
  • Patient registries
  • Diary and patient-reported outcome studies
  • Service evaluations and audits
  • Student and doctoral projects
  • Multi-site collaborations

EDC for observational studies

How it works

Seven steps from documents to final dataset

The same documented process applies to a single-site pilot and a multi-site study. Your team approves each key stage.

Study documents review

Send us your questionnaire/form, protocol and preferred output format. We flag anything that needs clarifying and agree the scope.

eCRF programming

Items, codes, validation rules, conditional logic and user permissions are configured to the agreed specification.

Internal quality control

We test structure, navigation, calculations, logic and data outputs before the database reaches your team.

User Acceptance Testing (UAT)

Your nominated users test the database. Corrections are documented, made and retested before approval.

Study activation (go live)

Once approved, the database goes live for data collection.

Study support

User administration, monitoring, technical queries and controlled changes during data collection.

Database closure and data delivery

Review, closure and controlled delivery of the final dataset in the format you need.

Choosing an EDC

A short checklist for investigator-initiated studies

Whichever system you choose, these questions are worth asking before the first participant is enrolled. They are the ones funders, ethics committees and journals tend to ask later.

How ResearchGuru is priced

Questions to ask

  • Who builds and tests the eCRF, and how long does it take?
  • Is every change to the data recorded, with the person, time and reason?
  • Can each site see only its own participants?
  • How are amendments made after the study has started?
  • Where are the data hosted, and how are they backed up?
  • In which formats will the final data be delivered?
  • Who answers when a site has a problem?
  • What happens to the database when the study ends?

Frequently asked questions

Investigator-initiated studies: common questions

Something else? Get in touch and a senior researcher will answer.

Yes. We can review a draft questionnaire/form and give you a scope and quotation to include in the application.

No. ResearchGuru is built for small studies as much as large ones, and the process is the same.

The data-entry screens are designed to be straightforward, and we provide practical onboarding and study-specific guidance where needed.

Yes. Amendments go through a controlled change process covering assessment, programming, testing and approval, so data collected before and after remain comparable.

You do. Data-processing roles, access, retention and final delivery are documented in the applicable agreement.

Tell us about your study

Send us your questionnaire/form and protocol, draft or approved. We'll review the proposed structure and come back to you with:

Start your enquiry

Or email admin@edcstat.com · call +44 7484 816484

  • An initial database-build assessment
  • Any questions or recommendations
  • A proposed delivery schedule
  • A clear scope of work
  • A project quotation

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