Time Tracking Software for Contract Research Organizations

A clinical trial can look profitable in the contract and lose money in practice. The gap opens quietly, through screen failures that consumed a week of coordinator effort, unscheduled safety visits nobody logged, monitoring visit prep that took two days instead of four hours, and reconsent work after an amendment that was never priced into the original budget. By the time finance notices, the study is half over and the hours are gone.

Contract Research Organizations run on billable labor. When that labor is recorded in memory, spreadsheets, or a system nobody reconciles against the sponsor contract, the CRO absorbs the cost. Time tracking software for contract research organizations exists to close that gap, turning the work your staff actually performed into evidence you can invoice against and margin you can measure per study.

actiTIME has worked with CROs and research groups for over 20 years, and teams in 130+ countries use it to connect hours to cost, billing, and project outcomes. This guide covers how a CRO can use it, and it is honest about where actiTIME stops.

Why time tracking is a financial control for CROs

Sponsors outsource to CROs for expertise, infrastructure, speed, and cost control. Those same pressures become the core challenges Contract Research Organizations face, and each one traces back to a question about hours: who worked on what, for how long, against which contract line, and did we get paid for it.

Budget leakage in clinical research rarely arrives as one large error. It accumulates through ordinary work. A coordinator takes a forty minute call about a rescheduled visit. A CRA spends an afternoon preparing for a monitoring visit and another responding to findings. A protocol amendment triggers retraining and reconsent across a dozen participants. None of it feels large enough to invoice, and none of it gets recorded, so the site or the CRO donates the labor.

The fix is unglamorous. Record effort at the point it happens, tie it to the study and activity it belongs to, and compare it against what the sponsor agreed to pay. Everything below is built on that.

Capture time where the work actually happens

Clinical research staff do not sit at one desk. A CRA is at an investigator site with unreliable connectivity. A medical writer works in long focused blocks. A coordinator handles fifteen interruptions before lunch. Ask all of them to reconstruct the week on Friday afternoon and you get fiction.

actiTIME offers four ways to record time, and CROs typically use more than one.

Time entry options:

Every entry carries an optional comment, which is where the narrative detail lives. A line reading “3.5 hours, Site 104” tells finance nothing. A comment reading “repeat screening labs after reflex test, subject 104-0012” is the thing that survives a sponsor query six months later.

Time tracking became a breeze

With actiTIME’s mobile app, tracking time on the client’s side became a breeze. Now accountants simply switch on the timer on their phone as they start another task and get accurate time logs without taking notes.

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Separate billable trial work from everything else

actiTIME organizes work as Customer, Project, and Task. All three level names are configurable, so a CRO can rename them to Sponsor, Study, and Activity, or to whatever vocabulary your contracts already use. Time is always recorded against a task.

On top of that structure, two features carry most of the weight for CROs.

Types of work mark an activity as billable or non billable and carry the billing rate. Data management, medical writing, pharmacovigilance, monitoring, and internal admin can each have their own rate. Assign a type of work to a task and every hour logged against it prices itself.

Custom fields let you categorize tasks by attributes actiTIME does not know about natively. Fields can be text, dropdown, or numeric with units and limits, which covers protocol number, study phase, therapeutic area, site ID, and amendment version. The Custom Fields Report then slices performance across those categories, so you can answer questions like how much coordinator effort Phase I oncology studies consume compared with Phase III.

Setting this up across a large study does not have to be manual. Tasks import from a CSV template, and bulk actions update priority, status, custom field, type of work, estimate, and deadline across many tasks at once.

See study margin, not just study hours

Most time trackers stop at the hour count. For a CRO that is the least interesting number. The useful question is whether the study earned more than it cost.

actiTIME answers it by holding two sets of rates. Cost of work rates sit on each employee, with separate regular, overtime, and leave rates. Billing rates sit on types of work. Once staff track time, three reports do the arithmetic.

Invoices come out of the same data. actiTIME accumulates billable amounts from time entries and billing rates, then generates a PDF invoice with your branding, taxes, and discounts applied. There is no separate invoicing tool to reconcile against, which removes one of the places where sponsor billing disputes usually start.

When a sponsor challenges a line item, the Time-Track in Detail Report gives you entry level backup for every hour, with the comment the person wrote at the time.

Catch budget overruns while you can still act

A budget you review at close out is a post mortem. actiTIME supports three independent budget types, and each one can sit at the customer, project, or task level, meaning you can budget a whole sponsor relationship, a single study, or one activity within it.

1. Cost budget.

   Tracks staff expense based on employee pay rates. Use it when your exposure is internal labor.

2. Billing budget.

   Tracks billable amounts against the contracted value. Use it to see how much of the sponsor’s budget you have consumed.

3. Time budget.

   Tracks hours invested against hours allocated. Use it for fixed scope activities like database lock or a set number of monitoring visits.

Each budget shows a progress bar that turns red once exceeded, viewable as a total or day by day. Admins can also receive an email the moment a project cost passes its budget, which is considerably more useful than discovering it during quarterly review.

Alongside budgets, task estimates test whether your bid was realistic in the first place. Set the estimated hours before the study opens, let the team work, then run the Estimated vs. Actual Time Report. The variance it shows per customer, project, or task is the single best input you have for pricing the next protocol. Sites that consistently underprice screening effort find it here.

Control who sees what, and lock the record

Trial work carries confidentiality obligations, and not every person should see every study. actiTIME handles this through work assignments. A manager assigns a customer, project, or task to specific people, and assigning a customer automatically includes its projects. Staff see only what they are assigned to. Role based permissions govern who can approve time, manage billing data, or change the scope of work.

Once hours are recorded, two features protect them.

Time-Track Approval lets staff submit a week with one click. A manager reviews it from the timesheet or the Approve Time-Track tab, approving or rejecting in bulk and adding a comment explaining a rejection. Each person can have several approvers but needs only one approval, and editing an approved timesheet rolls its status back so the change is visible.

Lock Time-Track then freezes entries so they cannot be edited after approval, after invoicing, or after a period closes. Managers can lock selected cells, specific days across all users, or every date up to a chosen cutoff. Pairing approval with locking is what stops a timesheet from quietly changing after you have already billed the sponsor.

For infrastructure control, actiTIME Self-Hosted installs on your own premises as a one time purchase, which matters when patient adjacent or commercially sensitive data cannot sit on a vendor’s servers. Two factor authentication, configurable password and account lockout policies, and daily backups on the cloud version cover the rest.

Resource CRAs without burning them out

Monitoring visits cluster. Database locks create crunch. Overtime in a CRO is not an anomaly, it is a seasonal pattern, and it costs real money that has to land somewhere.

Overtime Registration calculates overtime per user according to state and company regulations, in one of four modes ranging from fully automatic and hidden to manual entry by the employee. Overtime is paid at a separate rate set in the user’s profile, and that cost flows into the Cost of Work Report rather than disappearing. The Time Balance and Overtime Report shows work time against scheduled hours across the team, which is how you spot the CRA who has been carrying two studies for a month.

Leave runs on customizable leave types tied to PTO or sick day balances. Accrual rules run on a schedule, balances reset yearly or on hire date, caps prevent unlimited rollover, and leave requests are automatically rejected when the ending balance would fall below a threshold you set. PTO blackout days block time off during periods you cannot afford to lose people, such as a site initiation window. Leave carries an hourly rate too, so vacation and sick time appear as real cost in the Cost of Work Report.

For organizations with medical writers, statisticians, data managers, and clinical operations under one roof, user departments group people so reports can be filtered by team. Corporate calendars and per user work schedules handle staff spread across countries with different holidays.

Fit into the systems you already run

actiTIME is not trying to replace your CTMS or your EDC. It connects to them.

One practical use of Zapier at CROs is a change log. Pipe timesheet and task updates into Google Sheets and you have a running record of what changed and when, which is helpful during internal review even though it is not a formal system feature.

See where your trial hours go and what each study actually earns. Track time, cost, and billing in one place with actiTIME

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Pricing options for CROs

actiTIME is one product with no feature tiers, so a small research group and a global CRO get the same capabilities. There are three ways to buy it.

Overtime Registration, Time-Track Approval, Departments, Task Estimates, Custom Fields, the API, and the Chrome extension are not in the free version, and most of them appear somewhere in the workflows above, so a CRO evaluating actiTIME should run the 30 day trial rather than the free version. The trial is full featured, and every option includes human support and free onboarding. Full pricing details are here.

FAQ

What is the difference between a CTMS and time tracking software for a CRO?

A clinical trial management system runs the trial itself, handling protocol data, site management, patient randomization, and regulatory documentation. Time tracking software runs the business behind the trial, recording who worked how many hours on which study, what those hours cost, and what they should bill. Most CROs need both, because a CTMS will tell you a monitoring visit happened and will not tell you the visit cost you $1,400 in unbilled CRA time.

How should a CRO handle billable travel time to investigator sites?

Create a dedicated type of work for travel and give it its own billing rate, which may be lower than the rate for on site monitoring or zero if the contract treats travel as non billable. CRAs then log travel against that type of work using the Calendar view, which records exact start and stop times. Travel hours stay visible in the Cost of Work Report as real staff expense even when they bill at a reduced rate, so you can see what site coverage genuinely costs before you agree to the next geographic footprint.

Does actiTIME satisfy FDA 21 CFR Part 11 or DCAA audit requirements?

No. actiTIME does not provide a system wide audit trail, and it has not been validated as a regulated system of record for clinical trial data. It does offer timesheet approval workflows, time-track locking that prevents edits after a period closes, task level change history, and a self-hosted option that keeps data on your own infrastructure. If your sponsor contract requires Part 11 or DCAA compliant labor records, verify the requirement against those specific features with your quality team before selecting any tool.

Ready to try actiTIME in your Contract Research Organization?

The CROs that use actiTIME are usually not looking for another dashboard. They want to know which studies make money, which ones quietly drain a coordinator’s week, and whether the invoice they send on Friday can survive a sponsor asking where the hours went. Read how research organizations use it in our healthcare and research testimonials, or talk it through with our sale team.

You can start with the permanent free version for up to 3 users or run a full-featured 30-day trial at no cost.