Aquila CTPV is our CFR part 11 compliant pharmacovigilance database which was designed to facilitate the obligatory process of safety reporting within clinical trials in order to ensure the compliance with tight timelines and requirement for consistent data transmission. By using Aquila CTPV in your trial, you have taken a huge leap into the future of automated safety reporting, medical case reviewing and efficient data handling.

Aquila CTPV is available as stand-alone and in combination with DataMagik's DataKapture System.

Contact us now for more detailed information on Aquila CTPV and how we will use it within your trial.

AQUILA CTPV WORKFLOW

Within the clinical trial, the serious adverse event is brought to the attention of the investigator. Investigator logs on to Aquila CTPV and completes the SAE report. By applying the electronic signature, an e-mail notification including the pdf report is automatically sent to the Sponsor, NeuroScios PV Unit, Project Manager and NeuroScios Study Safety Officer (SSO) and Sponsor Medical Monitor (MM), as well as to the reporting investigator as confirmation. Both SSO/MM give their medical review within Aquila CTPV - with automated reports again being distributed to the involved parties. Investigator may complete a Follow-Up report with one click, while all previously completed fields are duplicated to ensure focus on new information to be delivered.

FREQUENTLY ASKED QUESTIONS

1.      Is Aquila CTPV E2B(R3) compliant?

No. As there are several E2B compliant databases in the field, there is no additional need for sole E2B gateway transmission databases. However, the elements of the safety report in Aquila CTPV are based on E2B data fields. Aquila CTPV focuses on facilitation of PV processes and reporting procedures. As business rules for ICSR reporting are constantly changing, and EMA is currently implementing HL7 as the new format for the electronic exchange of data, EMA’s EVWEB reporting system will be used by us for SUSAR transmission to competent authorities to ensure seamless compliance with regulations.

2.      Is Aquila CTPV adaptable?

Yes. Aquila CTPV offers individual adaptation possibilities according to the trial setting and is not limited to its version specification.

3.      Is data in Aquila CTPV safe?

Aquila CTPV is hosted via a remote desktop solution by companies with extensive knowledge of database hosting. Each Aquila CTPV database is hosted on a dedicated server specifically set-up for each trial, therefore information from any other study can never be accessible within an individually set-up Aquila CTPV database. Aquila CTPV is additionally equipped with the part CFR 11 compliant toolkit of Ofnisystems Ltd, which provides restricted data access, electronic signatures and an audit trail of data changes. Backups of the backend data file are generated by NeuroScios PV after each new entry to ensure data loss prevention. Furthermore, NeuroScios GmbH PV Unit will additionally save exported data files on their dedicated server, including Excel (*.xls) and Adobe Acrobat Reader (*.pdf ) files of reported cases and reviews.

4.      Is Aquila CTPV validated?

Yes. Aquila CTPV has undergone a validation process of all necessary features which was performed by NeuroScios CTPV. Validation reports are filed within the NeuroScios Pharmacovigilance System Master File. Ofnisystems LTD has separate validation documents on their Part 11 compliant Toolkit. Additionally, for each Aquila CTPV set-up for an individual trial or at version changes the general procedures are subject to another test procedures validation, which include the generation of study data (including study information, study investigators, sites and pv staff) as well as 3 test SAE cases (including Initial and Follow-Up), and both MM and SSO reviews.

Different standards and requirements apply to clinical trials conducted within the European Economic Area. With our expertise in the specific field of pharmacovigilance we are putting our focus and intentions on ensuring subject safety and guaranteeing to fulfill all necessary regulatory requirements when conducting clinical trials within the European Economic Area.

SERVICES  Management: Allocation of a legal representative within the European Economic Area for Sponsors based outside the European Economic Area and conducting clinical trials within the EEA. Registration of Sponsor at European Medicines Agency’s Eudravigilance Database according to European Legislation. We provide a responsible person for Eudravigilance, who is in charge of Submission of IMP information to EMA’s XEVMPD database according to Article 57 of EC Regulation No 276 / 2004. Submissions of SUSARs as ICSRs to European Medicines Agency’s EVCTM database according to European Legislation. Registration of MedDRA license for Sponsor, if applicable. Review and consultation for Study Protocol writing regarding safety measures.  Full SAE & SUSAR Handling: Preparation, Set-Up and Implementation of SAE Report Form and Pregnancy Report Form. Preparation of safety handling instructions and trainings for Investigators. Full SAE handling and management from Initial to Final version, creation of CIOMS for each individual case until finalization of the event. SAE follow-up requests and query handling with investigators until case resolution. Assistance in DSUR preparation for Sponsor and allocation of corresponding line listings of AEs and SAEs/SARs. Additional reporting of SUSARs to CAs, ECs and Investigators. Allocation of a Study Safety Officer. Consequent monitoring of AEs and SAEs throughout the study. Study Safety Officer Medical Review of SAEs. AquilaCTPV implementation - Instantaneously be up-to-date on all serious adverse events in your study at all time. Instant E-Mail notifications in case of SAEs and follow-up information. Organization and Set-Up of a Data Safety Monitoring Board/Data Safety Committee