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Clinical/LIMS Data Management

Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today

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 rooted 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.

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 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.

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.

Explore Our Clinical Data Management Services

  • 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

Stay In Touch

hr@shoolin-inc.com 732-929-7101

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