Clinical Data Department 
In addition to its phase I and IIa activities, and complementary to them, Optimed is clearly positioned as a major actor in the management of clinical studies, through its Clinical Data Department.

This department brings together the technical activities for Clinical Studies: monitoring, data management, statistics and medical writing. It allows us to offer not only complementary services for sponsors who carry out phase I & IIa studies in our Clinical Unit, but also to undertake the entire implementation of Phase IIb to phase IV studies, surveys & medical marketing studies.

MONITORING
All monitoring services are provided by an experienced team of Clinical Research Associates. Depending on your needs, our team can take in charge the whole study or just one part. For investigators selection, we can undertake the recruitment of doctors for your study or if you work regularly with a specific network, we can assume the set up and the monitoring of your centres. 

DATA MANAGEMENT AND STATISTICS
Concerning the Data Management & Statistics activity, everything is in place, from hardware to information systems, to ensure the confidentiality, security and traceability of your data. As with our monitoring services, the team can carry out different and specific activities.
The management of your clinical study data is looked after by an experienced team which can intervene at different steps  :

• Writing of data validation plan
• Database design & administration
• Data entry with double & independent keyboarding
• Data Validation
• Coding (MedDRA®, Who-Drug…)
• Blind Review
• Database freezing
• Database transfer

In relation to our policy of continuous development, the Clinical Data Department of Optimed has adopted a benchmark of the pharmaceutical industry for its Data Management activities : ORACLE CLINICAL®.

Building on our knowledge of ORACLE®, the migration to ORACLE CLINICAL® allows us to anticipate your expectations and improve our performance, whilst maintaining a very hich level of quality and meeting our deadlines.

In choosing o durable, user-friendly and progressive solution for the managament of all key data managament processes within one database, we are able to respond as closely as possible to your needs, as follows : 

•  capitalize on study designs adapted to your standards,
• adhere better to the regulatory norms (21 CFR part 11),
• resolve queries more rapidly.

  If you would like to know more about this recent development, please do not hesitate to contact us.

     MEDICAL WRITING
The last activity is Medical Writing. Our medical writer can take part in document definition from the study start (study design, writing of all study documentation, …) or can intervene at the end of the study for report writing (clinical study report, communication of study results, post-study meetings,…).
With all these services, our wish is to offer the best way forward to give you maximum efficiency for your clinical study plan.

 
SURVEYS AND MEDICAL MARKETING STUDIES
Thanks to its competencies in clinical research, Optimed is able to realize your surveys and medical marketing studies. Our experience allows us to understand the implications of surveys, which enable improved knowledge of drugs and pharmaceutical products. Optimed provides help and follow-up during all the steps of the survey, from the definition of the problem to the compilation of the conclusions.
The Data Management Department ensures reliable data collection and processing, and provides conclusions adapted to your needs.
Optimed commits itself to your project, and ensures communication and interactivity with a unique contact, the project manager in charge of your survey. We establish a transparency of our work with weekly reporting. 
Finally, the objective is to carry out a dynamic project thanks to  regular exchanges.
Optimed’s competencies are an asset for the understanding and conduct of surveys and medical marketing studies.