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Clinical Development
Challenge: 

Integrated Clinical Development Products


Solution:

PharmaVigilant's Suite of Products

Overview

The entire suite of products is specifically designed to streamline the clinical trial process and improve communication across different functional groups. 

 

Investigator Evaluation and Site Feasibility

Investigator evaluation and site feasibility is completely accomplished with our investigator portal.  Sites complete a CDA, review the synopsis and complete their questionnaires in less than 10 minutes.  Feasibility questionnaires are customized to the sponsor and can include the information needed to complete 1572s.  Questions can also be weighted based on their importance.  The clinical team is immediately notified by email when questionnaires are completed and can review the responses online.  The entire workflow for approval, need for site evaluation visits, and training for posting all regulatory documents is completely integrated in the process.  Sponsors can also use the site feasibility questionnaires to build a knowledge base by including actual site performance on the feasibility question. All feasibility questionnaires are stored in I-Warehouse and ad hoc reports can be generated at any time.

Online Monitoring Reports

Online Monitoring reports can be provided and completed online in a completely separate database.   Sponsors can raise queries online and signoff is also completed within the system.  Monitoring reports are stored in I-Warehouse and can be queried at any time.  Communication can be enhanced with PharmaVigilant's electronic monitoring reports.  For instance, automatic notification can be sent to the Help Desk and TMF manager when new site personnel are identified to ensure proper documentation, training, and account management is completed.

 

Central Portal 

Manage all activities and multiple studies from one location. The Portal enables Clinical to view and manage multiple studies at any time.  It includes data on enrollment, granular to the site level as well as overall data on number of subjects enrolled and number of queries.  Each user's view is customized to their roles and the number of roles is not limited.  For Clinical, it is extremely easy to access the top line results needed for reports and to manage all the activities of a trial from a single web location.  This includes regulatory documents, contracts, drug approval, randomization, safety document distribution, third party adjudication, and DMSB reports.

 

eTMF 

Collection of all regulatory documents online.  Instead of managing TMFs for all the sites as well as central files and reconciling them continuously, I-Vault enables you to maintain one TMF for the entire study.  Each site has their own location for their files.  Upon completion, the site is given a complete version of the TMF files on disk. This saves a significant amount of time and assures regulatory compliance.

 

Electronic Contracts 

Collection and maintenance of all contracts.  Contracts are stored within I-Vault but access is limited by role.  Contracts are provided on a separate archive disk, distinct from the regulatory documents for sites.

 

Third Party Vendor Documentation

Managing all documentation for third party vendors can be accomplished with I-Vault.  Each folder and each document can be viewed only by the roles that are specified by the Sponsor.  This means that all documentation for third party vendors can be maintained in I-Vault and only visible by the Sponsor and the specific third party vendor.

 

Safety Document Distribution

Safety Document Distribution can be delivered with I-Vault.  This enables the Sponsor to assure that they meet their timeline requirements for distribution to sites and IRBs.  In addition, PharmaVigilant provides the option for sites to confirm review of documents with electronic signatures.  

 

Integrated Randomization

Integrated Randomization eliminates the need for IWRS.  Randomization and drug assignment are integrated within the EDC solution.  This saves time for set up, eliminates complexity for the sites, and eliminates the need for reconciliation at the end of the study.

 

Online Patient Reporting

Online Patient Reporting patients can complete questionnaires online at the sites or from home.  This is useful for patient reported outcomes and for reporting SAEs or other data for outcomes studies.

 

Online Informed Consent

Online review of Informed Consents- Many Site Audit findings are due to problems with informed consents.  PharmaVigilant delivers the ability to collect informed consents, provide de-identification for the sponsor, and enable the review of all informed consents for appropriate version, number of pages, etc.

 

Remote SDV

Remote SDV provides the ability to have 80% of the simple verification activities performed remotely.  This provides immediate visibility into site problems and enables training or other remediation processes to be undertaken weeks faster than with traditional onsite monitoring.  This approach enables Sponsors to save up to 50% of their monitoring budgets.

 

Integrated Site Payment Report

Integrated Site Payment Reports  can be generated which include Sponsor-specific algorithms ( including data entered, whether there are open queries, whether document submission is complete, duration from subject visit to data entry, etc).  Reports are provided which provide the current payment and cumulative payments.

 

Drug Accountability Documentation

Drug Accountability Documentation-forms can be provided for each site to maintain the drug accountability.  This can be reviewed at site visits and the Sponsor can have complete visibility into the process through PharmaVigilant's system. 

 

Eliminate AE/SAE

Eliminate AE/SAE reconciliation-PharmaVigilant uses an integrated AE/SAE database that eliminates the need for SAE reconciliation.  Data are collected once and are used by both the Pharmacovigilance team as well as the clinical team.

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