Our Expertise

We are on-hand to advise and support all aspects of data capture and analysis from CRF design through to database lock. We have extensive experience in all phases of trials and work closely with both the clinical and reporting teams to ensure efficient collection and delivery of the highest quality data.

  • All of our principals have PhDs in statistics at leading universities, including Harvard, Stanford, and Columbia. They include nationally renowned experts.
  • We have knowledge and expertise across a wide range of software solutions and we partner with a variety of data management platforms in order to best support our clients’ individual needs.
  • Our clinical data managers provide you with the optimal solution for your clinical trial that will allow your study to go from first patient into database lock as quickly and efficiently as possible without compromising data quality or integrity.
  • We are a one-stop-shop for all data management activities from database build, through data cleaning and query resolution, to database lock and archival.
  • Our team members are focused on developing partnerships routed in quality, efficiency, and transparency.
  • The end result: cost-efficient data management; faster time to database go-live; a functioning, intuitive clinical database; expedited database lock; and ultimately, accurate and clean clinical trial data.

Our Approach

EXPLORE OUR CLINICAL DATA MANAGEMENT SERVICES

  • Cross-functional biometrics team plans
  • EDC, including accredited Medidata Rave support
  • Risk-based monitoring
  • IWRS
  • CDASH standard datasets
  • Consulting (strategic program planning, protocol review, EDC selection, etc.)
  • Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
  • Database design, development, and maintenance
  • Data validation programming and testing, inclusive of edit check and manual review specifications
  • Data entry, if applicable
  • Data cleaning and query management
  • Medical coding using WHODrug & MedDRA dictionaries
  • Serious adverse event (SAE) reconciliation
  • Management and integration of local laboratory reference ranges with CRF data
  • Integration, verification, and reconciliation of external electronic data
  • EDC selection and end-user training
  • Database lock and archival
  • Database transfer
  • Extensive edit checking
  • Site metrics for CRF completion and Query Resolution
  • Continual Quality Control review including audit trail logging
  • MedDRA and WHODrug coding
  • AMP, cell therapy studies, Observational, Device, and Marketing studies
  • 3rd party vendor oversight and data transfer planning

FLEXIBLE AND CUSTOMIZED DATA MANAGEMENT SOLUTIONS

Our Consultative Approach

We take a consultative approach to all data management activities. We will work with you to understand your ultimate goals and provide experienced feedback to get you there in an efficient and quality way. We have flexibility in our processes while still providing a quality infrastructure of the basic elements of data management.

  • We will consult with you early on to determine the right EDC solution for you, based on your current programs as well as your future pipeline. We can help balance short term goals against long term vision for your programs and plan proactively for each phase.
  • We will ask questions to drive key interim and final deliverables to completion based on our niche knowledge of what is needed and the steps to achieve each milestone.
  • We will help you understand the critical elements of data management, and how each item impacts other stakeholders. We realize not everybody is an expert in data management, therefore we strive to not just deliver operational milestones, but to help teach and guide you along the way.

All Data Managers are EDC-Certified Designers

All our data managers, at all levels, are certified designers in at least one EDC system. This means that the lead assigned to your study is knowledgeable about all database build considerations. Your data manager is also your database developer and vice versa – the skillset is all together in one amazing team member!

While we have partnerships with three separate EDC providers, and we are a Medidata accredited organization for EDC builds, we can still support your data management needs in any system.

A Proactive Approach to Data Management

Our processes support a proactive approach to each element of data management. Case Report Forms are built as SDTM compliant as possible from the start, with efficiencies gained from our in-house library of forms. Data cleaning is performed in as near real-time as possible to maximize query success rates and identify challenges early. Database lock is performed on a rolling basis.

We work smart. Databases are designed with the end-users in mind.

  • For example, we use dynamic search tools to publish fields that are expected based on previous entries – no need to ask site coordinators to know which questions are relevant and which should be skipped – we take the guessing game out of data entry.
  • Similarly, we focus our development of data management documents like the CRF Completion Guidelines to provide thoughtful information to sites instead of a wordy document providing common sense instructions.
  • We think proactively about our downstream stakeholders and how to balance each team members needs throughout the entire data management lifecycle. Our biostatisticians play an active role in not just initial CRF development, but any mid-study changes that may have impacts to programming and subsequent timelines and deliverables.

FREE CONSULTATION 

It is all about you. Let’s dive in.

 We want to hear about the specifics of your project. One of our experts will provide personalized recommendations and ideas. We will take the time to learn about your project and discuss how to help you.

This is a $200 consultation we are providing for free. What is there to lose?

Call us now at (669) 900-1414!

Contact us now