CT Manager is a SPARK Ada program for managing blinded clinical trials to GCP, EU Annex 11, and 21 CFR Part 11 regulations. It meets IEC EN 61508:2010 at SIL 3+.

CT Manager operates double and triple blinded clinical trial protocols in a manner which preserves blinding of investigators and sponsors, while making the decisions for dose escalation, pause, stopping or adaption are transparent and auditable.

A central server contains the encrypted source data, listing the trial name, protocol type, product serial numbers and randomisation. CT Manager reads the file, enables users in each class to login, and either read data, set up participants, enter data, request next action. Data is logged back to the central server in AES 256 bit encrypted XML, including the details of each session (who, did what, when, for how long, and the data entered).

CT Manager understands AE types, SAEs, SUSARs, and emails the appropriate parties configured for each event.

The real power of CT Manager is in its handling of randomisation: it enables trial data to be entered, escalation decisions or pause decisions to be made automatically, without revealing the blinding. CT Manager can also generate randomisation sequences, using a PRBS, including randomisation in sets where the proportion of items of placebo/reference treatment and the intervention can be set. For example, in a 3+3 dose escalation trial, it can generate the randomisation such that for each set of 6 participants there is an equal number of A and B markings given to each type of the drug/placebo.

Randomisation can be set to stay hidden thoughout the trial, be revealed once data for a participant has been entered (i.e. after the trial decision has been made by CT Manager based using the blinded data), or the DSMB & auditor user groups can request emergency unblinding.

CT Manager has a database of common phase trial designs. Addition of a new trial design is available as a customisation option for a fixed fee, including the re-verification of the implementation. The standard library includes the following trial design elements that may be combined for any one trial:

n+n Dose escalation,
Parallel arms
Parallel Group designs (PGD)
Randomised Placebo Phase (RPPD)
Factorial designs
Stepped Wedge (SWS)
Enrichment Enrolment Randomised Withdrawl (EERW)
Early Escape (EE)
Delayed Start (DS)
Three Stage (3S)
Adaptive designs
Cross-overs with predefined washouts
Ranomised Cluster Designs
Blind Reader Design (BRD)
Zelen's Design
Wennberg's Design