Configurable EDC Platform with Built-in TFLs
ResearchGuru combines a configurable EDC platform with fully managed eCRF programming, quality control, User Acceptance Testing, study monitoring and controlled data delivery.
Illustrative example
From approved documents to data delivery
Programming, question/item design and data-quality rules, all checked against your approved specification.
We fully manage eCRF programming from approved documents
Our programming service can include
elig_calc = 1status = 2quota_cellstatus = 3status = 1- Rest1
- Medication2
- Heat pack3
A flexible participant experience
Question/item types
ResearchGuru supports a broad range of form or questionnaire designs and data-capture requirements.
Depending on the agreed configuration, studies can include:
Forms are responsive and work on compatible mobile phones, tablets and desktop computers.
Online and offline data-capture arrangements can be considered, depending on the study requirements, device configuration and approved operating process.
Intelligent data-quality controls
Prevent avoidable errors at the point of entry
Data quality should be built into the eCRF, rather than fixed after data collection has finished.
Protocol-defined controls can include
These controls flag missing, invalid or inconsistent entries while the participant or researcher is completing the form.
The required checks are defined in the approved study specification and tested before activation.
piddobwt_kgbmi_calcHow satisfied are you with the product overall?
q12_satis1–5Dans l’ensemble, dans quelle mesure êtes-vous satisfait(e) du produit ?
q12_satis1–5ما مدى رضاك عن المنتج بشكل عام؟
q12_satis1–5製品全体にどの程度満足していますか？
q12_satis1–5One variable, every language, one combined dataset
Multilingual data collection
ResearchGuru supports multilingual studies using an agreed master questionnaire/form and controlled language versions. The platform supports more than 80 languages, subject to suitable translations being available and approved.
The multilingual process can include
ResearchGuru configures the approved translations but doesn't independently certify linguistic or medical translation accuracy, unless specialist translation review is included in the agreement.
Give each user only the access they need
ResearchGuru uses named individual accounts and study-specific access rights. Access can be separated by responsibility, for example:
Production access follows least-privilege principles. Permissions can control who can view study information, access specific sites, review records, export data or carry out administrative tasks.
Client users aren't given unrestricted rights to change live eCRF content or directly edit participant records. Changes to an activated study go through the controlled change-request process, and shared or generic accounts are not permitted.
| Role | View | Enter | Review | Export | Admin |
|---|---|---|---|---|---|
| Site user | – | – | – | ||
| Data manager | – | – | |||
| Monitoring user | – | – | – | ||
| Read-only reviewer | – | – | – | – | |
| System administrator | – | – | – | – |
| ID | Test · actual result | Status |
|---|---|---|
UAT-014 | q12 = 0 skips to Q15Q13 shown | Fixed · retested |
UAT-015 | BMI from height and weight24.2 as expected | Pass |
UAT-016 | Export name for smoke_ynExported as smoke | Fixed · regression run |
UAT-017 | Quota-full message, F 18–34Awaiting tester | Retest |
Study-specific validation and UAT support
Study documentation can include
Your nominated study users test the system against the approved requirements before giving activation approval.
Issues found during UAT are recorded, assessed, corrected and retested. Where a correction could affect functionality that has already been tested, targeted regression testing is completed.
Participant communication, scheduled and monitored
Where appropriate, ResearchGuru can support participant communication workflows such as:
The communication schedule, approved wording, sender details and opt-out requirements are agreed before activation.
No identifiable participant information should be uploaded or used until the agreed privacy, security and data-processing arrangements are in place.
- Day 0Invitation sent250 sent · 246 deliveredDelivered
- Day 3Reminder 1118 non-respondersScheduled
- Day 7Reminder 264 non-respondersScheduled
- Day 7Failed messages4 bounced · flagged for reviewReview
- OngoingCompletion confirmations181 sentSent
Illustrative example
Secure participant access
ResearchGuru supports both restricted and open participant-access models to match your recruitment model.
Personal information and research responses are handled according to the agreed data model, privacy requirements and user permissions.
Oversight while data collection is live
Safety triggers, operational dashboards, recruitment quotas and participant follow-up.
- Study
RG-CARDIO-01- Participant
RG-0142· Visit 2- Trigger
ae_yn = 1 and ae_ser = 2- Recorded
- 10:42 by j.okafor (Site 03)
Automated notification to support timely review. Seriousness, causality and reportability are assessed by the study team.
Conditional safety notifications
Protocol-defined triggers for responses that need prompt review
Triggers may include
When a response meets an approved condition, the system starts a notification workflow to nominated study personnel. The trigger, recipients, notification wording and escalation arrangements are agreed during study specification and tested before activation.
A system notification supports timely human review. It does not determine clinical seriousness, causality, expectedness or regulatory reportability.
Real-time operational dashboards for authorised users
Depending on the study, metrics can include
Dashboards can include charts, time-series views, geographical maps, pivot tables and configurable filters. Reports can be filtered by time period, location, site, participant group or recruitment status, and agreed reports can be downloaded or shared with authorised colleagues.
Study metrics dashboards support study management and fieldwork oversight. Formal statistical analysis is provided separately where it's included in the agreed service.
Illustrative example
| Quota cell | Fill | n | Status |
|---|---|---|---|
| Female 18–34 | 30/30 | Full | |
| Male 18–34 | 24/30 | Open | |
| Female 35–54 | 28/30 | Open | |
| Male 35–54 | 30/30 | Full | |
| Female 55+ | 17/30 | Open | |
| Male 55+ | 13/30 | Open |
redirect · status = 3Illustrative example
Monitor the quotas while recruitment is active
Recruitment quotas can be configured using approved participant characteristics, eligibility conditions and study targets.
Quota functionality can support
Quota logic is tested on an activated UAT copy, because full quota enforcement may not be available in preview mode. Changes to live quota targets are treated as controlled study changes and recorded in the Study Change Log.
Tables, figures and listings, inside the EDC
RGTables turns study responses into numbered TFLs and analyses, with traceability built in.
RGTables 2.0: TFL dashboard
Regulatory-style outputs, generated from live study data
Choose the study, tick the analysis variables, stratify the columns by any categorical variable (treatment arm is picked up automatically) and group the rows by visit. Add a Total column, p-values and filters on any variable. Every heading is editable, footnotes are written for you, and saved outputs carry TFL numbers (Table 14.1.x, Figure 14.2.x, Listing 16.2.x) and re-run on the current data each time they are opened.
Statistics and analyses
Exports: Word (.docx) with repeating heading rows, RTF for SAS-style workflows, CSV, PNG and SVG figures, PDF, or all saved outputs in one document with a contents page.
Traceability: each output shows the project, extraction time, record count and, with the audit-trail plugin, the audit-trail entry and hash at extraction. Exports and saved-output changes are written to the audit trail.
Every method was verified against an independent implementation on a demo study (agreement to at least 6 significant figures). Outputs support monitoring, exploration and reporting; final submission analyses are reproduced in the validated software named in the SAP.
| Arm A N = 71 | Arm B N = 71 | Total N = 142 | ||
|---|---|---|---|---|
| Systolic blood pressure (mmHg) | ||||
| n | 70 | 69 | 139 | |
| Mean (SD) | 128.4 (14.2) | 131.1 (15.0) | 129.7 (14.6) | |
| 95% CI | (125.0, 131.8) | (127.5, 134.7) | (127.3, 132.2) | |
| Median (Q1–Q3) | 127 (118–138) | 130 (121–141) | 129 (119–139) | |
| Sex, n (%) | ||||
| Female | 38 (53.5%) | 35 (49.3%) | 73 (51.4%) | |
| Male | 33 (46.5%) | 36 (50.7%) | 69 (48.6%) | |
Illustrative example
Data exports, ready for your analysis
ResearchGuru provides controlled data exports in agreed formats.
Formats can include
Variable names, response codes, missing-value conventions, calculated variables and delivery formats are defined during study specification. Where needed, test extracts can be reviewed during UAT to confirm the database structure meets your planned analysis.
External datasets can also be combined with agreed dashboard sources where technically appropriate and within the project scope.
Documented, traceable and access-controlled
Validation and UAT, audit trails, role-based access, participant access models and change control.
Who did what, what changed and when
ResearchGuru supports system-generated audit records designed to show who performed an action, what changed and when it happened.
Audit-trail controls can support
Participant records that have already been collected are never silently overwritten. When an authorised correction is needed, the original value, corrected value, reason, user and timestamp all remain traceable.
ResearchGuru procedures require the audit trail to stay active and prohibit uncontrolled direct changes to production response tables.
| Time | User | Field | Change |
|---|---|---|---|
| 10:42:07 | j.okafor | sbp_v2 | blank → 212 |
| 10:58:31 | j.okafor | sbp_v2 | 212 → 122 |
| 11:05:12 | r.patel | ae_ser | Query raised |
Controlled post-activation changes: Protect data comparability after go-live
Uncontrolled changes to an active eCRF can affect data integrity and make records collected before and after a change hard to compare. ResearchGuru uses a documented eCRF Change Request process:
Each assessment considers existing participant records, variable definitions, response codes, routing, calculations, data exports and study documentation.
Emergency changes can be prioritised, but they still follow the documentation, testing and approval requirements.
RGTables 2.0: TFL dashboard
Regulatory-style outputs, generated from live study data
Choose the study, tick the analysis variables, stratify the columns by any categorical variable (treatment arm is picked up automatically) and group the rows by visit. Add a Total column, p-values and filters on any variable. Every heading is editable, footnotes are written for you, and saved outputs carry TFL numbers (Table 14.1.x, Figure 14.2.x, Listing 16.2.x) and re-run on the current data each time they are opened.
Statistics and analyses
Exports: Word (.docx) with repeating heading rows, RTF for SAS-style workflows, CSV, PNG and SVG figures, PDF, or all saved outputs in one document with a contents page.
Traceability: each output shows the project, extraction time, record count and, with the audit-trail plugin, the audit-trail entry and hash at extraction. Exports and saved-output changes are written to the audit trail.
Every method was verified against an independent implementation on a demo study (agreement to at least 6 significant figures). Outputs support monitoring, exploration and reporting; final submission analyses are reproduced in the validated software named in the SAP.
| Arm A N = 71 | Arm B N = 71 | Total N = 142 | ||
|---|---|---|---|---|
| Systolic blood pressure (mmHg) | ||||
| n | 70 | 69 | 139 | |
| Mean (SD) | 128.4 (14.2) | 131.1 (15.0) | 129.7 (14.6) | |
| 95% CI | (125.0, 131.8) | (127.5, 134.7) | (127.3, 132.2) | |
| Median (Q1–Q3) | 127 (118–138) | 130 (121–141) | 129 (119–139) | |
| Sex, n (%) | ||||
| Female | 38 (53.5%) | 35 (49.3%) | 73 (51.4%) | |
| Male | 33 (46.5%) | 36 (50.7%) | 69 (48.6%) | |
Illustrative example
Data exports, ready for your analysis
ResearchGuru provides controlled data exports in agreed formats.
Formats can include
Variable names, response codes, missing-value conventions, calculated variables and delivery formats are defined during study specification. Where needed, test extracts can be reviewed during UAT to confirm the database structure meets your planned analysis.
External datasets can also be combined with agreed dashboard sources where technically appropriate and within the project scope.
Secure hosting and backup
ResearchGuru uses controlled hosting, access management and backup processes to support the availability and protection of study data.
The hosting location, data residency, backup frequency, retention period and security responsibilities are documented in the applicable service agreement.
Project-specific arrangements can cover
See how your study would be built
Send us your questionnaire/form and requirements for an initial database-build assessment, a proposed delivery schedule and a quotation.
Or email admin@edcstat.com · call +44 7484 816484