eCRF – clinical
trial software

Safety and credibility of clinical trials.

Non-commercial clinical trials

Commercial clinical trials

Research

Compliant with FDA standards

Our eCRF is:

Integrated with the hospital system

Flexible, adapts to changes in the test protocol

Configurable for any protocol

Quick to implement

Intuitive to use

Doesn't require extra training

Our eCRF solution was created on the basis of many years of experience of researchers and medical teams with whom we carried out research projects. The system is, above all, easy to use, user-friendly and extremely flexible.

The prepared solution meets all the required quality standards, and thanks to the full control over the code, we can further develop and adapt it to the changing requirements of regulators and the clinical trials market.

The eCRF TTSI
system will allow you to:

1

Support multiple clinical trials in one place

Our eCRF supports the process of designing and managing multiple clinical trials. In each study, a view of the full list of patients is available, showing the stages they are currently in with the possibility of managing a given patient in the study (randomization, dispensing / returning of test products, management of patient samples).

2

Designing a clinical trial

The system enables the creation of a clinical trial in accordance with its protocol and schedule, reflecting the full structure of the course of the clinical trial. It enables the ongoing implementation of modifications resulting from the approved next version of the clinical trial protocol.

3

Randomization

The system enables configuration of randomization in a given clinical trial, taking into account e.g. appropriate randomization method and study arms. The randomization process is carried out in the application automatically by assigning a randomization code based on the criteria specified in the Study Protocol.

4

Managing the test product

eCRF allows you to keep a register of tested products and monitor their condition by notifying the supplier of the demand for delivery of a batch of products, marking defective / disposed of packaging, and alerting the user about the upcoming expiry date of the package. The system enables the dispensing of products to the patient, and in the case of blinded studies, it automatically takes into account the arm to which the patient was assigned during randomization. In addition, it allows you to track the full history of the circulation of a given product.

5

Sample register

The eCRF system allows you to keep a register and monitor all stages of processing samples with biological material collected in a given study, which are often sent to an external supplier / laboratory for diagnostics.

Advantages of our eCRF system:

  • Automatic generation of a unique code for each newly introduced patient, according to the rules defined in the study.
  • Automatic sending of notifications to a defined group of recipients; for example, about a reported adverse event.
  • Tracking changes for each event reported in the system (Audit Trail) – viewing the history of all data edits entered into the system.
  • On-the-fly data validation and the ability to query entries (Data Query). Marking of checked data and, in the case of detection of irregularities, applying a query to an attribute.
  • Automatic randomization with assigning the patient a randomization code.
  • Distribution of the tested product – full synchronization with the tested product management module.
  • Create forms that are then used in the study wizard to map the schedule.
...
...
...

Data validation reduces the possibility of entering erroneous information, and also enables the detection of deviations during data entry, by:

  • A wide range of different types of attributes (single / multiple-choice dictionaries, numeric, logical, text fields, section, static text, date and time fields, dynamic / static tables, file upload field, images).
  • Edit check – requires normalization on the attributes, i.e. conditions that will be verified on an ongoing basis, after entering data into the attribute. The system displays an appropriate message to the user if the value entered in a given attribute does not meet the standard, e.g. as in the case of laboratory tests.
  • Requires logical conditions on attributes under which data filling is available.
  • Overlaying validators on attributes (maximum number of characters / maximum value, minimum number of characters / minimum value, required field).
  • Forms versioning

Turn data into knowledge!

Range of services

... ... ...

We work with:

Ask us a question

KAMIL SIJKO
DATA SCIENCE DEPARTMENT DIRECTOR

kamil.sijko@ttsi.com.pl | phone: +48 885 870 180

www.ttsi.com.pl
sales@ttsi.com.pl
phone: +48 661 900 265
NIP: 527-294-32-09 | REGON: 387666213 | KRS: 0000872108

Personal data processing clause

TRANSITION TECHNOLOGIES SCIENCE Sp. z o.o.