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Complete Trial

Challenge:

Eliminate Multiple Vendor Interfaces

Solution:

PharmaVigilant's Suite of Products

Complete Trials - Complete Programs

PharmaVigilant's solution enables sponsors to have one place to go for everything needed for a trial.  This eliminates more than 10 different interfaces for the sites, enhancing their experience and building their relationship with you.

 

  • Site Feasibility and Selection:  From the very first step in a study, identifying sites and completing site feasibility, PharmaVigilant delivers a custom portal where sites can register and  complete sponsor-specific CDA's and feasibility questionnaires.  Instead of taking days and hours of staff time, the entire process takes less than 10 minutes for the site.  There are automatic notifications when sites have completed their questionnaires and entire workflows to support site visits, site training, and site upload of regulatory documents.

  • Regulatory documents, IRB documents, contracts, third party vendor documents can all be stored and managed in a single location, I-Vault.  The robust roles and privileges determine who can see a specific document or folder, who can download that folder, and who can sign a document .  The flexibility and ease of use of I-Vault enables many different functional groups to work within the same system.  Sites appreciate a "one stop shop" for everything they need.  Contracts staff can maintain contracts, safety teams can distribute IND Safety reports and PSURs,  while the regulatory team can review all the documents to approve shipment of Clinical Trial Materials.  Each works within the system without seeing the documents the other is working on.

    I-Vault enables you to identify documents that are expired, have flags indicating errors and to identify documents that have been uploaded within a specific timeframe, by site or across an entire study. You can set up notifications when documents are uploaded to any user within the PharmaVigilant system-sites, sponsors, or CROs.

  • Images are a tremendous challenge for companies.  Whether it is angiograms, MRIs, or other images, they can be uploaded by the radiologist and read by a central reader anywhere in the world.  With InSpire, third party reviewers can provide their review of the images directly into the EDC system-with or without investigators being able to see the results of the review.

    Don't worry about the size of the database for all your documents and images; I-Vault can handle it. Don't worry about wanting to have huge flexibility in the number of  roles within I-Vault whether it is 30, 50 or 100 different roles; I-Vault handles it with ease.  Don't worry about exporting to documentation systems,  I Vault delivers.

  • Patient Data:  Whether you need to store source documents associated with an SAE or to assure that your informed consents are correct to eliminate site findings from audits,-Vault delivers de-identification.  This enables Sponsors to be totally protected from personal identifying information.  You can also collect data directly from subjects within the PharmaVigilant system.  This saves time and money in getting patient reported outcomes.

  • Data and Safety: PharmaVigilant's EDC system provides an efficient method to collect data for a trial, randomize subjects,  manage SAE reporting, review  labs, ECGs, patient reported outcomes,  and  perform safety assessments.  You can also manage monitor reports and clinical trial material status at the sites-all within the same system.  The system is extremely flexible, and can be branded for the Sponsor or the Asset.  You save time at data lock because you eliminate the need for AE/SAE reconciliation, the need for reconciliation with an IWRS system, and the need to reconcile for coding since it is also done within our EDC system.  Labs can be reviewed and clinical significance assigned in the EDC, saving time for lab reconciliation too.

    Data Managers have immediate access to the datasets for the trial and can download them at will.  Data can be exported as standard SAS datasets or as SDTM data sets.  This enables the Data Managers to work on their timeframe and not have to worry about scheduling data downloads.

  • Monitoring reports can be collected directly into InSpire in a separate database.  We enable the completion of the monitoring report, review by the Sponsor and sign off by the Monitor-all within the system.  With monitoring reports, team members can be immediately notified of changes in site personnel.  Automatic notification to the Help Desk assures that personnel that have left are locked out of the system and new personnel can be scheduled for training.

  • Remote Source Document Verification delivers cost savings of 50% over traditional SDV done onsite.  Instead of settling for reduced SDV which still leaves you exposed if there are errors in the data, with rSDV, sponsors can have 100% SDV at a cost similar to that of reduced SDV.  It is easier and less risky to implement than reduced SDV models.  rSDV is completed within a week of a subject's visits, enabling faster identification of issues and faster remediation. All source documents are maintained as eSource-assuring improved compliance. 

  • Clinical trial material reports can also be maintained within the system, providing visibility into the supplies at a site. 

  • Site Payment reports can be generated at any interval you need.  We can provide reports within a few days of the end of the month, enabling Sponsors to pay sites two weeks after they have completed data entry for the month.  This builds a tremendous incentive to work on your studies.

  • Programs, not just studies: PharmaVigilant's technology addresses the way Pharma, Biotech and Device companies develop their Assets.  The I-Warehouse enables Sponsors to access and perform unlimited ad hoc queries of the data from all their trials.  All of the data from the forms in PharmaVigilant's EDC are updated nightly into the I-Warehouse and data from pre-existing trials can be imported into I-Warehouse.  I-Warehouse is the only clinical data warehouse that enables cross study reporting.  Reports can be developed and regenerated at will.  They can be exported into Excel or as time-date stamped PDFs.


PharmaVigilant Delivers Our Functionality Fast

The build takes one week for I-Vault and 4 weeks for the EDC to Go Live following final specifications approval. PharmaVigilant's suite of products delivers the smart and cost effective solution for Clinical Research-from start to finish.

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