Frequently Asked Questions

Here are some answers to most common questions we get.

General Questions
 
What is the Single Interface™?

The Single Interface™ is a role-based, single login site for all the information and tools that are needed to effectively interpret and manage your clinical trials and programs. Through our Integrated Analytics module, a countless number of configurable report structures are ever ready. Users are also able to filter the data to create Ad Hoc reports. Diverse data sources can be correlated to reveal hidden patterns, trends, associations and insights that are important for patient safety. All without breaking the blind. There are many other modules under the Single Interface™ so that, if needed, it can be a complete clinical development platform.

Is the Single Interface™ an Electronic Data Collection (EDC) system?

The Single Interface™ can include EDC as one of its optional modules. Alternatively if you have an EDC system, it can integrate the EDC data into one central repository. Improved norms are achievable with the Single Interface™ whether using our EDC or a third-party EDC. The benefit of our EDC is that it standardly reports substantial performance data and process metrics. However, when integrated with another EDC, the platform will still provide early observations into not only your aggregated data, but also the suppliers generating and responsible for cleaning and locking the data. This information can be leveraged to drive the suppliers to achieve your milestone on time(i.e., what gets measured gets done). It can also identify trends around queries and monitoring that can be used to informatively manage your CRO better.

Is the Single Interface™ a Clinical Trial Management System (CTMS)?

The Single Interface™ can include what is typically considered CTMS functionality through several modules such as the Monitoring System, the Grant Navigator and Clinical Project Accounting system in conjunction with our Integrated Analytics.

What additional functionality does Prevails’ Platform have?

Most likely, we have every functionality you are looking for! Some of Prevail’s systems and tools at your disposal are:

  • Best-in-Industry Analytics, Reporting Engines and Visualizations
  • Electronic Data Capture (EDC) system
  • Clinical Data Management (CDM) system
  • Integration Platform with data reconciliation and consolidation of external data
  • Randomization and Trial Supplies Management (RTSM) system including Interactive Voice/Web Response System (IxRS) and a Supplies Management System
  • Clinical Monitoring System
  • Clinical Trial Management System (CTMS) functionalities
  • Pharmacovigilance (PV) System including Pharmacovigilance Database (PVD) and Clinical Data Review
  • Document Management System
  • Electronic Trial Master File (eTMF)
  • Investigator Grant Tracking and Payment System (Navigator)
  • Project Accounting/Budget/Payment Management System
  • Benchmarking Database
  • Business Development Platform called TruPoints™, including eCTD mapping
  • Patient Diary
  • Reimbursement Platform
  • Data Warehousing
How is Prevail different from other systems?

For over 15 years Prevail has been outperforming other systems by integrating all sources of information in a study and providing game-changing analytics and process management tools, resulting in increased study data quality, improved timelines and reduced costs. You will find that our ability to integrate almost any data source differentiates us from pure data visualization software companies and our ability to report complex analytics and decision-supporting metrics differentiates us from everyone else. Multiple NDAs that used the Prevail system have been approved by the FDA. Most recently we successfully passed an FDA inspection in 2014 which lead to an FDA approval of a new drug in 2015.

Can the Single Interface™ be used in all therapeutic areas?

Yes, Prevail has conducted hundreds of studies in all major therapeutic areas and is well-suited for any therapeutic specialty because of its information and process know how. The therapeutic areas we have worked with include: Allergy / Immunology, Auto-Immune, Bio-defense, Cardiovascular, Dermatology, Endocrinology, Gastroenterology, Hematology, HIV/Infectious Diseases, Internal Medicine, Men’s Health, Metabolic Diseases, Musculoskeletal, Neurology, Oncology, Ophthalmology, Orthopedic, Pain Management, Respiratory Transplantation, Urology / Nephrology, Vaccines, Women’s Health

How long does it take to launch a Single Interface?

Depending on which modules and tools are chosen, a system can be launched within two to six weeks. Integrating external data only and providing analytics or process-management tools takes two to four weeks. CRF development of a full EDC and CDM system takes four to six weeks.

Can we develop the system ourselves?

It is recommended that Prevail develops the Single Interface™ Platform to start, but sponsors or third parties can then configure the system and develop CRFs themselves. Alternatively Prevail can set-up the system quickly and cost-effectively from start-to-finish.

How much does it cost?

The Prevail Single Interface™ as a whole is priced competitively and provides the most technology-per-dollar-spent in the industry. Pricing is transparent with a 100%, no-questions-asked satisfaction guarantee: if you are not satisfied with your results, your payment is returned.

Do I have to buy the entire platform or can I pick and choose the modules I want?

Yes, the system is modular and modules can be licensed individually or in combination for a study or multiple studies. There is no minimum cost and component are available for adding mid-study

Can the Sponsor/CRO provide Data Management?

The sponsor/CRO can perform their own data management. Alternatively, Prevail has Data Management services.

What type of clients do you have?

Prevail has worked with hundreds of clients, ranging from major pharmaceutical companies to biopharma, biotech and virtual companies of all sizes as well as medical device companies, diagnostic companies and CROs.

Do you work with CROs?

Prevail has worked with the largest CROs in the industry as well as medium/niche providers with great success in multiple geographies. This also includes knitting together consultants and any internal/external resources.

technical questions
 
How can you access the system?

The interface layer, depending on application, is delivered in thick and thin clients on PC, tablet PC and iPhone/iPad devices. Typically both site and sponsor/CRO personnel are provided with a secure webpage to access the system through a browser. After completing the appropriate training users are provided with a unique user name and credentials to log onto the Single Interface™.

Who gets access the system?

Access to the system is role-based and for example can support roles for site coordinators, site investigators, site pharmacists, clinical monitors, lead monitor, logistics managers, safety specialists, accounting specialists, contracting specialists, project managers and data managers. There are also specific roles for un-blinded personnel dealing with randomization and study drug supplies.

How is the software implemented in site or hospital network, what are the requirements?

Prevail’s Single Interface™ is a web-based application accessible using standard web browsers, eliminating the need for any software to be implemented locally at the hospital site.

Is there any limit to the number of users of any kind?

There is no limit on the number of users for any role/function.

Do you have CRF templates or do you use CDASH structures?

We have a library of CRF templates or can develop CDASH template structures and will optimize them to collect the data needed for the study as well as the workflow for the site users.

Can you provide data transfers in SDTM/ADaM?

We can provide datasets in an operational format (ODM) or in SDTM/ADaM.

How long does it usually take from LPLV (last patient last visit) to DBL (data base lock)?

Prevail’s norm is to target an accelerated database lock within 48 hours of receiving the last patient data, assuming Prevail is implementing its own platform and has control of data processing functions.

Are queries issued while the study is still ongoing?

Yes, with the Single Interface™ data management tools, data management and monitoring teams have access to real-time data from all data sources to review, reconcile and query. This enables the ongoing data cleaning from the first patient visit to the last, leaving minimal cleaning after last patient out. At any point in the study, about 70-85% of the data is clean and soft locked and can be easily monitored for verification and oversight.

Does your system have the ability to process complex and multivariate database queries to generate data outputs?

Yes, Prevail has a tool that allows your data management group as well as members of the clinical team to define search criteria on any piece of data that is collected and integrated and produce listings. Also, the data validations are defined in a cross dataset manner.

How is central lab data merged into the data base?

Prevail collaborates with the central lab to create specifications for integrating and reconciling the central, specialty or affiliate laboratory data with the clinical database. Prevail configures the study-specific central lab integration using Prevail’s core integrations platform, which provides efficient and seamless interoperability between our Single Interface™ and external data sources. Regularly scheduled integrations, consolidation, and reconciliation of central lab data commences at a frequency agreed to with the sponsor.

Quality assurance questions
 
Does Prevail have a Quality Management System with adequate SOPs? Does Prevail perform compliance audits?

All activities performed are governed by a robust Quality Management System which includes 36 policies, 84 standard operating procedures (SOPs) and 77 associated documents that govern the regulated tasks and responsibilities of Prevail’s personnel when conducting clinical trials. All SOPs are viewed biennially and audits for compliance are conducted annually through internal and third party audits.

Is your platform validated?

Prevail’s Single Interface™ and its modules are delivered through a pre-validated platform architecture designed to provide rapid deployment and cost-saving efficiencies which are supported by an experienced staff and Quality Assurance department personnel trained in the company’s SOPs for the development, installation and use of the Single Interface™. The validation is supported with complete documentation on installation, development, validation and study-specific acceptance testing prior to release – user acceptance testing by a third party can be made available. The Prevail Single Interface™ and its modules are designed, specified, developed, tested, validated and delivered according to US and international regulations, FDA’s 21 CFR Part 11 and ICH GCPs guidelines.

How secure is the system?

All primary systems are virtualized in a physical hosting facility that is certified as IS027001, SOC 2-Type 1 and SSAE 16 Type 1. Both primary and secondary physical hosts are globally-redundant systems providers and data is transferred through 128-bit SSL encryption. All data exchange is completed in a MDK5 encryption on both the upload and download.

Do you have Business Continuity and Disaster Recovery Plan?

All of the Prevail data systems are operated and backed up in redundant, geo-dispersed environments, hosted by two of the world’s largest cloud providers. Prevail maintains detailed Backup and Recovery and Business Continuity procedures that are tested and validated on a regular basis.

Have any products you worked with been approved by the FDA?

Multiple drug and device products have been approved for marketing by the FDA based on datasets generated from Prevail’s systems.

Have you been audited?

Yes, we successfully completed an FDA inspection in 2014 and no 483s or warning letters were issued. We successfully undergo and welcome sponsor requested audits by third party vendors for prequalification.

Training and support questions
 
How do you support your studies?

Prevail provides customer support services in the study and sponsor regions during their normal business hours wherever the study is being conducted. If necessary, additional support service can be provided to provide translational services in the study site’s local language.

How do you perform the training?

Role-based training can be provided a multiple formats. In person training, e.g. during Investigator Meetings can be provided. Additional training webinars can be provided to the sponsor, CRA and site teams. These training sessions are recorded and made accessible to study team members unable to attend the live webinars or in-person sessions. For sites, training attendance or viewing of the recorded training is a pre-requisite to issuance of user credentials for access to the EDC system. Monitors are provided “train the trainer” materials so they can train new site personnel if needed. Sites will also receive a quick reference sheet on how to perform functions (enter data, change data, respond to queries, etc.) as well as a CRF completion guideline. All training materials are available on the Single Interface™.

Do you operate internationally and where have you conducted studies?

Prevail has conducted dozens of international studies in over thirty countries on six continents across multiple time zone and language barriers.

How do I start?

Please feel free to Request a demo, call us at (267) 797-2001 or email us at info@prevailinfoworks.com.