A new study takes shape
The program needs an efficacy study for the lead anti-CD20 candidate in a CD20-positive lymphoma xenograft. Tumor cells are implanted in immunodeficient mice and left to engraft; once the tumors reach a target volume of roughly 100–150 mm³, the mice are randomized into four groups of ten: a vehicle control and three escalating dose levels. Dosing starts, and over the next three weeks, tumor volume and body weight are measured twice a week, with tissues collected at the endpoint.
Setting the study up is mostly saying what it's part of and who's in it. The study scopes to its project and the test articles the cohort will receive, anchored to a zero day the rest of the timeline counts from. Its treatment groups go in as vehicle, low, mid, high, with each tied to the batches it will be dosed with, so the dosing plan is part of the study rather than a separate protocol. Then the cohort enrolls in one pass, with forty animals entered together all at once instead of one form forty times, each animal assigned to its group. From that point on, the study holds the whole design in one place: the groups, the animals, the doses each group gets, and the program the work serves.
The cohort gets dosed
The animals are housed, the dosing protocol is approved, and the first dose is due.
Dosing is recorded against the live cohort, not a separate ledger: the dose lands on the actual subjects in their groups, drawn from the same batches the groups were already tied to. Nothing needs to be copied between a protocol document and the
study record because the dose is already a part of the record. Each animal's dosing history builds as the doses go out, and an animal moved between arms over the course of the study carries both treatments on its record, so a crossover is visible at a glance rather than reconstructed later.
Measurements come in on schedule
The cohort is dosed and the study is running. Body weight and tumor volume are due twice a week, and the technicians need the readings to land in the right rows fast.
Measurements come in the way they're taken at the cage rack: in bulk. Select a date and the form for the required measurements on each animal appears based on the study schedule, or download a spreadsheet template for the day's operations and upload it back to Affinity. Deaths are logged as they happen, with cause, so the cohort's attrition is current the moment it's known instead of reconciled at the end. The unusual one-off read still works one animal at a time, but the schedule is built for throughput. The observations that surround those numbers, the clinical signs and protocol notes recorded through the study, are written up in the lab notebook, kept in the same platform as the structured record rather than a separate binder.
Tissue samples land in inventory with their donor lineage
The terminal time point arrives. Tissues from the animals need to land in the freezer with their donors and anatomical sites attached.
The harvest is donor-linked from the first entry. Each tissue comes in associated with the animal it came from and where on the animal it was taken, entered in bulk so a thirty-animal harvest is one submission, not thirty forms, all of which drops into the freezer at the end. The donor link connects a tissue back to its subject, that subject's group, and the study that produced it, and each animal's record lists every tissue taken from it, so the bank in the freezer and the cohort from the study never drift apart.
The study reads out
The dosing window has closed, the measurements are in, the tissues are banked, and the question now is what the study showed.
The study reads out where it ran, against the same records the technicians produced, not a re-typed spreadsheet. Mortality becomes a survival curve per group, so the arms' attrition stacks up side by side. The scheduled measurements of tumor volume and body weight become per-group trajectories on a built-in plot, with assay data from the harvested tissues available as well. And when the study was built as a dose range, the effective or inhibitory dose can be computed with a dose-response fit. The picture that goes into the program review is the study itself, not a copy of it.
