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Data Management

The avaibility and the consistencies of data are the major challenge in your studies. We made them as our leitmotiv and when the trials or the surveys are carried out by Altizem, the Data Management activities performed by Altizem team provide our customers high quality data and this is done in the best timelines. Thereby, our experimented Data Managers carry out any kind of projects by using different methods, according to the requirements of every customer.

Paper CRF” Data management - [Find out more]

Being involved in many large scale projects for many years, we are able to offer you our expertise and to carry out your international projects.
We adapt us to your expectations and can provide you solutions according to your target.

e-CRF Data management - [Find out more]

Listening to your needs, we provide you support for the set-up of your projects on e-CRF, by using either the tool “Inform” in collaboration with “Phase Forward” or other e-CRF tools. We adapt us to your project. Thus, we use many different tools.

Direct Management of the trial.
Significant time saving.
Best quality of data.
A privileged communication tool.

Pooling - [Find out more]

The current needs urge you today to perform analysis on group of studies by using “Data Pooling” of studies that have been performed on different means. We became experts on this field and know how to homogenize your databases by collecting necessary information related to the development of your data.

Expertise

Database design - [Find out more]

Annotated CRF.
Database design and set-up (structure and data entry screen).

CRF and DCF flow - [Find out more]

Tracking of CRF and DCF receipt.
Data Management status and follow-up.

Internal Data Entry - [Find out more]

Writing data entry guideline.
Training of data entry people on Data Entry Conventions.
Single Data Entry.
Interactive double data entry.
Independent double blind data entry.
Quality control of data entry.

External Data loading - [Find out more]

Laboratory data.
ECG ...

Coding - [Find out more]

Coding of Adverse Events, Medical Histories, ECG reading and medications performed by a coding specialist with MedDRA, WHOdrug dictionaries or any other dictionaries provided by the Sponsor.

Validation - [Find out more]

Write data validation plan (edit checks).
Program test and validate data validation edit checks.
Generate listings of data validation edit checks.
Manage queries.

Patient Profile - [Find out more]

Define and program patient profile specifications according to the needs of the Sponsor.
Data layout and interaction with Expert Committee.

Data Review - [Find out more]

Drafting of Data Management Report.
Preparation of Data Report Review.
Data Review meeting.
Intermediate and final database lock.

Each stage and documents are validated by an independent Data Manager before sending them to the Sponsor.

Tool knowledge

To comply with regulatory requirements, we were equipped, from the beginning, with the best software packages validated by the FDA (Clintrial and SAS) and since several years now, we are using the e-CRF. Furthemore, we have internally developed a study management tool: Altitrack, in order to optimize the follow-up of your studies or surveys (24/24 h and 7/7 days).

We have a recognized expertise in term of new technologies, we adapt to your requirements as we have the experience.