At PMI, we know that client budgets and project objectives vary. Therefore, our software and hardware IT capabilities are designed with an eye toward scalability. This enables us to provide options best suiting our clients’ clinical data and information processing needs.

Web-enabled Technologies
Our eCDM applications are developed and maintained through our third party software developer, a developer of Internet-based applications to facilitate acceleration of clinical trials with proven software for study design, data capture, and data management.

Clinical database design can be performed rapidly and query development/validation can be done in real time. User training is provided and documented using our third party software developer Accelerated Learning™ on-line training platform. Clinical data entry can be done in a controlled, timely manner. Data monitoring and query generation/resolution may be completed well in advance of site monitoring visits. And, there is 24/7 data access and review for assigned users throughout the duration of a trial.

Study administration is also enhanced by the availability of secure, study-specific, collaborative web portals for email, documents, data extracts, study metrics, and news items.

Clinical Programming
PMI’s experienced systems analysts provide programming support in compliance with 21 CFR Part 11 for seamless collection, storage, and extraction of clinical study data and information.

Data Management
Effective data management services facilitate efficient access, processing, summarization, and dissemination of data and information. At PMI, our data management services incorporate leading-edge technology, 21 CFR Part 11 compliant systems, and experienced clinical data management personnel to support both electronic clinical data capture (EDC) and traditional Case Report Form (CRF) double data-entry applications.

Our data management services are scalable to your needs and emphasize well-organized, appropriately documented, accurate and timely processing of your clinical data. Service areas include:

  • Case Report Form (CRF) Design
  • Clinical Data Management Plan
  • Clinical Database Development
  • Clinical Data Entry
  • Data Dictionary Processing
  • Data Imports
  • Data Exports
  • Data Quality Assurance
  • Database Lock and Data Transfer
  • Database Maintenance and Archival
  • Security Procedures

PMI’s systems are configured to facilitate rapid restoration of data in the unfortunate event of server failure. Clinical data and programming files are stored on servers located in a secure, environmentally controlled area within PMI’s corporate office in Costa Mesa, CA, and backed up at an off-site hosting facility, which uses standard best practices with respect to data security.

Biostatistics and Clinical Programming
Clinical studies are performed for a variety of reasons — preliminary evaluation of safety (first in human, dose escalation, etc.), assessments of efficacy (comparisons of dosage levels, comparisons vs. gold standard, etc.), or performance/user preference comparisons versus alternative products or treatments. Regardless of the study objectives, statistical expertise is critical to running a successful trial that will yield valid results.

At PMI, our statisticians and clinical programmers have experience with trial design and data analysis across a broad range of medical specialties and therapeutic areas. They have been involved in various types of trials, including preliminary, early-phase studies, pivotal studies for regulatory submissions, and post-approval/marketing studies. PMI provides statistical and clinical programming support for each stage of the clinical study process — before, during, and post-study.

Pre-Study
Careful planning in the design phase will not only provide that the data collected can be used to evaluate the study hypotheses, it can also increase efficiency and decrease costs. More…

During the Study
Once a trial has begun, the Biostatistics and Clinical Programming Team can provide a variety of services so that valuable inferences can be drawn from the data at the conclusion of the study. More…

Post-Study
After the clinical data has been entered and cleaned, the Biostatistics and Clinical Programming Team work together to determine whether or not the study’s objectives have been met. More…

Additional Support More…

Quality Control More…

 

 

 

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