✓ provides instant and easy availability 24/7


✓ handles unlimited numbers of trial sites and investigators


✓ can be configured for a variety of different randomisation methods


✓ provides true concealed schemes for static and dynamic allocation


✓ can be weighted in favour of a certain treatment


✓ offers support for multiple strata


✓ supports multiple studies for the same investigator


✓ simplifies the matching of inclusion and exclusion criteria


✓ generates automatic notifications to study participants for case randomisations


✓ generates user specified reports

TrialObjects' Trial Manager™ is organised in a three level hierarchy for administration of the randomisation process. From the top down;
- Study Manager
- Site Coordinators
- Investigators

Study Manager
The Study Manager is often the primary investigator or someone directly assigned; in larger multi centre studies several managers may be allocated.
A Study Manager (SM) has full administration rights of the study and can name new investigational sites as well as appoint Site Coordinators. The study manager can also administrate the automated information generated by the system, i.e. reports and randomisation alerts.
The Study Manager is informed of all randomisations performed, both accepted and denied, in real-time.
The Study Manger has admission to the randomisation log of the whole study.

Site Coordinators
The Site coordinator (SC) administrates the system on site level. At each site the coordinator can qualify and recruit investigators and manage the sign-in process for the site’s investigators. Site coordinators have access to the randomisation log at the site.

Investigators
Investigators perform the randomisation and can observe performed randomisations on a personal level.

When a new trial is initiated, TrialObjects configures the specific study, stratification, number of sites, estimated number of randomisations as well as the Study Manager, initial Site Coordinators and initial Investigators.

Features

Randomisation method
The TrialManager™ can be configured for a variety of different randomisation methods and provides true concealed schemes for static and dynamic allocation.
Multiple strata can be configured, which can be weighted in favour of a certain treatment.

Randomisation Qualifications
If wished, each case to be randomised can be evaluated for matching inclusion/exclusion criteria for the specific trial. If the study is stratified this process will guide the allocation of the case to the right stratum. The Study Manager can manage the qualification criteria.

Reports
Automated reports of randomisations performed can be distributed at chosen intervals.

Multiple Studies
TrialManager™ also supports multiple studies for the same investigator. Sign in and choose study.

Cross platform
TrialManager™ has been tested on several web browsers and physical platforms: Microsoft Internet Explorer, Firefox, Safari, Google Chrome. It can be operated from PC, Mac, tablets, and smartphones.

TrialManager™ is a scalable solution which means that it will fit a small trial as well as a very large one, at an affordable price.

TrialRandomiser can within reason be configured with an unlimited number of strata, investigators, sites and inclusion criteria. It can be run over a short or a longer or shorter time although we as standard provide a 24 months open time.

The set-up will be done together with one of our experienced researchers.

There are no limitations on how many randomisations you use within this time frame. There are no periodic costs what so ever during the 24 months, just pay the set-up cost and that’s it.

We will set up a full scale test study using your data about the study, with numbers of strata, inclusion criteria, sites, investigators etc.

The limitation is that the methods are not in a permuted block order in this stage, they are sorted in a 1:1 order (A-B-A-B-A-B-A-B-A-B…). Whenever the actual trial starts this will of course be corrected.

The fee for setting up the test environment is 20% of the total cost and is deductible when you place an order on the the full TrialRandomiser™.

As soon as the full fee is paid we will start the TrialRandomiser™ for your study with the actual blocks and results.

And you are ready to go, Twentyfour-seven!

Fill in this simple form and one of our advisors will contact you and discuss a solution for your study.

Random allocation or randomisation introduces a deliberate element of chance into the assignment of treatments to subjects in a clinical trial.

During subsequent analysis of the trial data, it provides a sound statistical basis for the quantitative evaluation of the evidence relating to treatment effects. It also tends to produce treatment groups in which the distributions of prognostic factors, known and unknown, are similar. In combination with blinding, randomisation helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments.

The randomisation schedule of a clinical trial documents the random allocation of treatments to subjects. In the simplest situation it is a sequential list of treatments (or treatment sequences in a crossover trial) or corresponding codes by subject statistical Principles for Clinical Trials number.

The logistics of some trials, such as those with a screening phase, may make matters more complicated, but the unique pre-planned assignment of treatment, or treatment sequence, to subject should be clear.

Different trial designs will require different procedures for generating randomisation schedules. The randomisation schedule should be reproducible (if the need arises). Although unrestricted randomisation is an acceptable approach, some advantages can generally be gained by randomising subjects in blocks. This helps to increase the comparability of the treatment groups, particularly when subject characteristics may change over time, as a result, for example, of changes in recruitment policy. It also provides a better guarantee that the treatment groups will be of nearly equal size.

In crossover trials it provides the means of obtaining balanced designs with their greater efficiency and easier interpretation. Care should be taken to choose block lengths that are sufficiently short to limit possible imbalance, but that are long enough to avoid predictability towards the end of the sequence in a block.

Investigators and other relevant staff should generally be blind to the block length; the use of two or more block lengths, randomly selected for each block, can achieve the same purpose. (Theoretically, in a double-blind trial predictability does not matter, but the pharmacological effects of drugs may provide the opportunity for intelligent guesswork.)

In multicentre trials the randomisation procedures should be organised centrally. It is advisable to have a separate random scheme for each centre, i.e. to stratify by centre or to allocate several whole blocks to each centre.

More generally, stratification by known important prognostic factors measured at baseline (e.g. severity of disease, age, sex, etc.) may sometimes be valuable in order to promote balanced allocation within strata; this has greater potential benefit in small trials. The use of more than two or three stratification factors is rarely necessary, is less successful at achieving balance and is logistically troublesome.

The next subject to be randomised into a trial should always receive the treatment corresponding to the next free number in the appropriate randomisation schedule (in the respective stratum, if randomisation is stratified). The appropriate number and associated treatment for the next subject should only be allocated when entry of that subject to the randomised part of the trial has been confirmed.

Details of the randomisation that facilitate predictability (e.g. block length) should not be contained in the trial protocol. The randomisation schedule itself should be filed securely by the sponsor or an independent party in a manner that ensures that blindness is properly maintained throughout the trial.

Access to the randomisation schedule during the trial should take into account the possibility that, in an emergency, the blind may have to be broken for any subject. The procedure to be followed, the necessary documentation, and the subsequent treatment and assessment of the subject should all be described in the protocol.