A bioequivalence study is short, tightly scheduled and unforgiving about times. Capture records the period, sequence, dosing, actual sampling times, safety checks and deviations in one study with an audit trail, then exports clean data for your bioanalytical and pharmacokinetic team. Free sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | P1 Day -1 | P1 Dosing day | P1 Day 2 | P2 Day -1 | P2 Dosing day | P2 Day 2 | Follow-up |
|---|---|---|---|---|---|---|---|---|
| Eligibility and consent | ||||||||
| Randomized sequence recorded | ||||||||
| Dosing record (product, time) | ||||||||
| Blood sample times (actual) | ||||||||
| Vitals, ECG and adverse events | ||||||||
| Safety labs |
x = collected at this visit
What a bioequivalence study needs from data capture
The design
A bioequivalence study asks whether two formulations of the same active ingredient deliver it to the bloodstream at a similar rate and extent. The common approach, described in regulatory guidance, compares peak concentration and total exposure for a test and a reference product in healthy subjects, using a 90 percent confidence interval around the ratio of geometric means, usually judged against an 80 to 125 percent limit. The classic design is a randomized crossover: volunteers are assigned to one of the possible sequences, receive the products on separate occasions, and there is a washout between periods. Fed, fasting, replicate and parallel designs exist for particular products, and the protocol, built on current product-specific guidance, decides which applies to you.
None of that analysis happens in an EDC. What an EDC contributes is the integrity of the inputs. If a volunteer was dosed 12 minutes late, or a blood draw was taken outside its window, or the product given in period 2 does not match the assigned sequence, the person who analyses the concentration data needs to know, and the monitor needs to see how it was recorded. So the clinical record is organised around the unit of analysis: volunteer, period, product, nominal time and actual time.
Because the study is short and the analysts work from structured files, a good data capture plan is small. It lists the forms, the key time fields, the checks and the export specification, and does so before the first volunteer is screened. The protocol synopsis generator and equivalence trial sample size calculator help with early planning, and the sample size stays a statistician’s decision.
In most clinical studies a visit date is enough. In a bioequivalence study the sample draw times are the data. Record the nominal (scheduled) time point, the actual date and time of the draw, and a reason when the actual time falls outside the allowed window. Capture can calculate the minutes between two date-times as a read-only field during entry, so the deviation from nominal is visible immediately; the protocol decides which deviations are acceptable and how they are handled in the analysis.
Dosing and sample
Product administered
EXTRTDosing date and time
EXSTDTCNominal sample time
PCTPTActual draw time
PCDTCMinutes after dosing
PCELTMOutside +/- 2 min window, give reason
Reason for deviation
PCDEVRProtocol to build
| Study element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Screening and eligibility | History, vitals, ECG, labs, inclusion and exclusion | Eligibility form, medical history, vital signs, lab results |
| Consent | Signed, countersigned consent before any procedure | eConsent |
| Sequence assignment | Randomized sequence and period order | Randomization in the same study; see randomization software |
| Dosing record | Product, dose, date and time, fed or fasted state | Per-period eCRF form |
| Sample collection record | Nominal and actual time, sample ID, deviation reason | Per-period eCRF form with calculated minutes after dosing |
| Safety | Vitals, ECG, adverse events, concomitant medications | AE form, concomitant medications |
| Data transfer | Clinical data to your analysts and laboratory | CSV or Excel exports with data dictionary; SDTM export |
Capture records the clinical data. Bioanalytical concentrations and pharmacokinetic analysis are done outside Capture.
Create the dosing and sample forms in the free sandbox, enter practice volunteers across two periods and see how deviations are flagged. No credit card.
Safety and quality
Volunteers in bioequivalence studies are healthy, so the safety bar and the expectation of clean data are both high. Capture records vitals, ECG and laboratory values with edit checks, range rules and auto-queries when a value breaks a rule. Calculated fields such as QTc by the Bazett or Fridericia formula appear read-only during entry, and the QTc calculator is a quick standalone check if you want one. Adverse events carry severity, seriousness and relationship as separate fields, and the investigator keeps the clinical judgment.
Every change is written to a field-level audit trail with the user, time, old value, new value and reason. For a short study with many time fields, that trail is how a monitor or auditor reconstructs what happened without relying on memory. Forms follow a draft to approved lifecycle and approved forms are locked for live use, so the CRF cannot drift mid-study. The wider compliance picture is on the 21 CFR Part 11 compliant EDC page; Capture provides Part 11-aligned controls and compliance depends on your validated use.
Small clinical units and sponsors running their own studies can keep the clinical data in one place without an enterprise contract. EDC for CRO-independent trials explains how teams run without a CRO.
Build sequence
List the forms, time fields, windows and the export layout the analysts expect, with the protocol open.
Upload the protocol for an AI draft of visits and forms, or start from templates. A person reviews everything before it is saved.
Range checks on vitals and labs, minutes-after-dosing calculation, required reasons for out-of-window samples.
Run practice volunteers through both periods and look at the exports in the format your analysts need.
Approve the forms to lock them, start the paid live phase and screen the first volunteer.
Before first volunteer
Time zone, clock source and what counts as the actual draw time.
Allowed deviation for each nominal sample time and what happens outside it.
How test and reference are identified on the form without unblinding anyone who should not know.
The file structure your analysts and laboratory expect.
Clinic staff have entered a full practice period.
No. Capture records the clinical data, including dosing and sample times, safety and deviations, and exports it. Concentration data and PK or statistical analysis are handled by your laboratory and analysts.
Yes. Randomization and eCRF forms are in the same platform, so the assigned sequence and each period’s product and times can be recorded and checked. The schedule and washout rules come from your protocol.
A calculated field shows minutes between two date-times, an edit check can flag values outside your window, and a reason for the deviation is captured. How deviations are treated in the analysis is your protocol’s decision.
Yes. CSV and Excel exports include an automatic data dictionary, and SDTM datasets can be exported as SAS XPT with Define-XML.
Yes. It is self-serve, so you can build and test in the free sandbox before paying to go live. See the pricing page.
Build and test your bioequivalence study in the free sandbox. No credit card, and you pay only when volunteers are enrolled.