|
Description
of our services
| Project
design |
| • |
Drafting
of protocol and of case report form. |
| • |
Study
Proposal Preparation. |
| • |
Translations
and adaptations of protocols and case report form. |
| Monitoring |
| • |
Processing
of clinical trial authorization procedure with SHA, IECs, AACCs
(Autonomous communities). |
| • |
Processing
of contracts with supplying organisations, Centres, etc. |
| • |
Site
selection. |
| • |
Qualification/selection
visits. |
| • |
Monitoring
visits. |
| • |
Closing
visits. |
| • |
Clearing
out of “queries”. |
| • |
Attendance
at and organization of investigators’ meetings. |
| • |
Medication
recount. |
| • |
Main
and investigator´s file |
| • |
Experimental
medication management. |
| • |
In situ monitoring. |
| • |
Distance
monitoring. |
| • |
Monitoring
tasks ‘in- house’ at client’s own offices. |
| Complementary
services |
| • |
Management
and distribution of the study material (printed matter, transport,
etc...). |
| • |
Selection
of centralised laboratories. |
| • |
Payment
to investigators, centres, etc. |
| • |
Organization
of meetings. |
| Data
management |
| • |
Pre-entry
validation and codification. |
| • |
Recruitment
control. |
| • |
Data
entry. |
| • |
DB
design and filters. |
| • |
Issue
of data management queries. |
| • |
Closure
of data base and “freezing”. |
| Statistics |
| • |
Sample
calculations. |
| • |
Writing
of statistical section of the protocol. |
| • |
Statistical
programming. |
| • |
Preparation
of statistical reports. |
| Evaluation
of results |
| • |
Preparation
of clinical-statistical integrated reports. |
| • |
Writing
of scientific articles for publication. |
| • |
Preparation
of posters for Congresses. |
| • |
Presentation
of results to investigators. |
| New
technologies |
| • |
Remote
data entry (Internet or PDA portable devices). |
| • |
Publication
of results by Internet. |
| Pharmacovigilance |
| • |
Complete
pharmacovigilance management service. |
| • |
Preparation
of periodic safety update reports. |
| • |
Preparation
of pharmacovigilance Standard Operating Procedures. |
| • |
Customised
computerised data base design for adverse reaction management. |
| • |
Advisory
service. |
| • |
Pharmacovigilance
training for laboratory staff. |
| • |
Pharmacovigilance
management from the client’s own offices. |
| • |
Adverse
reaction communication management. |
| Quality
assurance |
| • |
Individualized
preparation of Standard Operating Procedures in all areas of
clinical research and pharmacovigilance. |
|
