Randomization and drug management

and Drug Management.

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Aktywne badania

What is randomization?

Randomization is a process of assigning participants to individual therapeutic and control groups, with the assumption that each patient has an equal chance of being assigned to each of the arms. This is a crucial part of the clinical study whose goal is to achieve a similar initial characteristics of patients in the compared groups, and thus reduces the risk of drawing misleading conclusions from the results of the clinical study.

Czym jest randomizacja?

Types of randomization.

simple
randomization

block
randomization

stratified
randomization

covariate-adaptive
randomization

How to avoid bias in clinical trials?

Blinded study.

Blinding is used to reduce a likelihood of bias in clinical trials.

Single-blinded study - type of clinical trial in which only a patient does not know which treatment or what kind of intervention (s)he receives until the end of the study.

Double-blinded study - type of clinical trial in which neither a patient nor an Investigator do not know which treatment the subject is receiving.

Interactive Randomization System.

Interactive Web Response System (IWRS) - is a module allowing randomization according to a preestablished randomization schedule. IWRS is fully customizable, system integrated with eCRF.biz^TM, that enables Sponsor to proactively manage key aspects of the clinical trials which include registration, randomization, dosage, drug dispensing, clinical supply, drug management, breaking blind, etc.

The status management of investigational medical products (IMP) allows trackinga history of blinded drug kits and display to the physicians kit numbers from the assigned study arm.

IWRS is user friendly and easy to access from anywhere in the world. In addition to the service and 24/7 availability, IWRS has many other advantages that make it attractive in clinical trials, notably large-scale studies,especially those with various treatment arms, and complex dosing schedules.

Interaktywny system randomizacyjny

Advantages of IWRS.

Scalability
that enables
recruitment and management
of a large number of patients.

zalety

Robustness
that helps to conduct
multiple studies
at the same time.

zalety

Real-time response
allows unique assignment
of patients numbers.

zalety

zalety

Easy integration
with other system
(e.g. eCRF) is possible.

zalety

Straightforward implementation
regardless of the type of study,
number of subjects and sites,
therapeutic areas.

Other eCRF system functions.

Protocol deviation log

Automatic reports

Online contracts

MedDRA dictionary

Clinical trials

Drug clinical trials

Medical device clinical trials

Non-commercial clinical trials

Observational studies

Pharmaceutical market research

Research and development

Medical registers

Data management

Trainings and consulting

Real-World Data

Digitization of the data collection process

Frequently asked questions.

What does the abbreviation RCT stand for?

It's none other than Randomized Controlled Trial, which is a clinical study with randomization. It is characterized by the random selection of patients for the research trial and the experimental group. In layman's terms, they are often called trials.

Are randomized clinical trials reliable?

The most significant advantage of these studies is that they are characterized by a high degree of credibility and allow researchers to minimize confounding factors. Randomized trials are a tool that provides vast opportunities for gathering information about therapy efficacy and its safety.

What is the purpose of randomization?

Randomized studies are a prevalent choice when it comes to clinical trials. It can be said that their primary goal is to ensure the reliability of the process. This can be achieved by random division of individuals, which quickly and straightforwardly eliminates prognostic factors.

Can we conduct RWE studies here?

Of course, RWE studies, or Real World Evidence, are also studies carried out by our staff. They are an excellent solution because their results can complement data obtained from clinical trials. RWE studies also provide information about the effectiveness of therapies conducted in real-world clinical practice conditions.

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