pddetrials - a web-based clinical data solution

Pacific Data Designs, LLC and ClinPro, Inc. are now ClinOps, LLC.

Data Management

ClinOps, LLC offers a full suite of Data Management services including:

Case Report Form (CRF) Design

  • Flexibility – ClinOps provides flexibility in the design of CRFs to adhere to your protocol and conventions. We customize each form to make it easy to gather the appropriate information and to facilitate accurate data recording and entry.
  • Convenience – ClinOps can coordinate the printing of all CRFs or trial related materials with our preferred vendors to increase efficiency of the study start–up process.
  • Tracking – ClinOps can track CRFs individually, at the visit level or at the casebook level using standard page numbers, unique pre–printed form numbers or even barcodes to identify pages. All CRFs and DCFs are tracked upon receipt and delivery and logged into our data management systems, allowing clients access to a variety of reports at their fingertips.

Database Design & Development

  • Customization: Our databases are custom designed to meet your study’s specifications. We review the trial protocols, CRF designs and take into account any convention requests prior to designing the clinical database. ClinOps can also incorporate a wide selection of features, including range checks for individual variables, intricate cursor movement, and pop-up selection lists.
  • Validation: Each database is fully validated and test data is entered prior to trial commencement to ensure data is accurately being captured.

Data Capture

ClinOps offers two primary methods for data capture: Paper-Based and Electronic Data Capture. Our project team will work with you to determine the most efficient and effective method to fit your needs.

Paper-Based Data Capture

ClinOps performs independent dual data entry for all paper based studies. With electronic data reconciliation of all our entries, ClinOps can minimize data entry errors.

Electronic Data Capture (EDC)

The most intuitive EDC system in the industry, pddEtrials® takes EDC one step further, providing a system designed by end users and Sponsors that allows data to be entered directly into your clinical database through a web–based portal, without any additional software. Data is immediately accessible after entry, eliminating delays in data uploads that many other EDC systems have.

Quality Control (Discrepancy Management/Query resolution)

To ClinOps, ensuring that your data is clean and accurate is paramount. For each study, ClinOps develops a detailed Data Management/Data Quality plan (DMDQ) in collaboration with our clients. The DMDQ is customized for your study and details all data handling procedures, edit checks and processes used to ensure the quality of your data.

Customized Reporting Features

ClinOps offers our clients a number of reporting tools for both paper-based and EDC trials. These range from customized Excel reports to data reports in Microsoft Access format, which you can create and run for real-time updates on your clinical data. Reports can be saved and re-run at your discretion 24/7 just by logging into the data management web–portal.

SAE Management

ClinOps provides an effective Serious Adverse Events (SAE) management tool as part of our data management system. SAE information is initially faxed or electronically entered into our secure ClinOps SAE Management System. The system provides you with email notifications and allows you to review the data within 24 hours of receipt. Our system also allows for easy export to MedWatch forms (or other regulatory forms), which can then be submitted to the regulatory agencies by a client representative. We work closely with our clients and monitors to build a comprehensive safety plan and ensure that all safety data is recorded and complete, in accordance with FDA regulations.

MedDRA & WHODrug Coding

ClinOps provides coding for all adverse events and medications using the most current versions of the MedDRA and WHODrug ATC Level IV Classifications coding dictionaries. We maintain previous versions of these dictionaries to allow the option of selecting one consistent version for your study. Our coding practices are of the highest quality and we have an in–depth level of knowledge on the workings of MedDRA and WHODrug. An advanced "matching" algorithm ensures a high hit rate while auto coding. With manual coding, a powerful dictionary search tool provides ongoing help as a "perpetuate" feature and automatically codes other identical items. Each medication is coded by our expert coding staff in order for the glossary to build on itself. ClinOps can also incorporate your internal glossaries. All coding is reviewed internally at ClinOps and is ultimately approved by you. Consistent coding is the key to grouping adverse events and medications for final statistical analysis and we have garnered great expertise with these systems.

External Data Import (Data Loads)

ClinOps routinely handles importing of data from many different outside sources. We receive and load data files such as central laboratory, pharmacokinetics, diaries, core laboratory, etc. We maintain relationships with multiple vendors and our knowledge of external data issues ensures quick and efficient validated data loads. ClinOps manages this process from data specifications through import and QC into the clinical database.

Imaging & Documentation Center

ClinOps understands how important it is for our clients to have immediate access to all study documentation. We offer an extensive imaging and documentation system that scans and stores images of CRFs, DCFs and other study documentation, such as protocols, DMDQs and draft analysis tables and listings. We also have the capability to upload medical images, photographs, x–rays, patient diaries, quality–of–life forms and other source documents, providing instant access from anywhere in the world. This ability is especially valuable for monitors while on the road or working at home. Data can be captured via email or fax through our Optical Character Recognition (OCR) software. All scanned documents are posted directly to our Data Management systems and stored in .PDF format according to ICH guidelines for electronic submissions to the FDA.

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