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CLINICAL TRIAL MANAGEMENT

Data Management

From database design and setup through data cleaning, reporting and database lock, Linical empowers clients with on-time, high-quality clinical data by using the latest technologies, efficient processes, and regulatory-compliant data management platforms.
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Linical provides sponsors flexible data management solutions based on cost, timelines, study size and clinical strategy.

Clinical Data Management Services

High-quality data is central to your clinical trial’s success and regulatory approval. Data management (DM) must ensure the security of sensitive information related to patients and the clinical trial as well as compliance with established data privacy regulations. Linical’s DM capabilities are designed to give you accurate and actionable data, in a timely manner ensuring the integrity, reliability, and efficiency of information management.

We have the necessary experience, resources, and processes to guarantee efficient data management throughout the clinical trial. Our 20+ years of experience in clinical data management spans trials across North America, Europe, and Asia, and we have worked on numerous global projects ranging from phase I, II, and III clinical trials to late-phase, observational studies . Linical’s data management team has expertise using the industry’s top electronic data capture (EDC) platforms including Medrio, Viedoc, and Medidata Rave, allowing us the flexibility to meet the specific data management needs of our clients.

Services

Comprehensive End-to-End Data Management Capabilities

Linical’s approach to delivering a clean, analyzable database is achieved through careful design of the data collection system, methodology for reviewing the data, and close collaboration with the other Linical study management functions. Our core competencies in data management come from our knowledge of standards, our compliant systems, and our effective use of commercially available data management platforms. Linical’s turnkey data management services include:

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Study Setup
  • CRF and database design
  • Data management plan development and documentation
  • Data validation and query management
  • CCGs
Study Conduct
  • Medical coding (WHO Drug and MedDRA)
  • SAE reconciliation
  • External data transfers and reconciliation
  • Ongoing data review, logging, and tracking
  • Data validation and clean up
  • Data quality assurance
  • Data management reporting
  • Secure central lab electronic data transfer and upload
  • CDIS (Clinical Data Interchange Standards Consortium) datasets
  • EDC Help Desk
Study Close Out
  • Database lock and audit
  • Database release using sponsor format (SAS, CDISC (SDTM, define.xml), etc
Expertise Across EDC Systems
  • Medrio
  • Viedoc
  • Medidata Rave

Your Dedicated Partner for Data Management

Linical combines experience with technology and therapeutic knowledge to ensure efficient processes, actionable outcomes, and the highest quality data. No matter how big or small your project is, our DM team listens to your specific needs and offers recommendations that best fit your project, adding value every step of the way.

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Data Management Oversight

Linical’s team follows best practices and well-documented processes in which the Clinical Data Management Lead (CDML) is responsible for coordinating all aspects of clinical data management including the following tasks:
Supervising all CDM documentation and change control
Leading them development of a targeted data cleaning strategy
Project status reports
Vendor management
Managing all CDM project-level deliverables
Oversight on EDC development, testing, implementation, and maintenance
Proactive collaboration with the PM, CRA, programmer, biostatistician, and medical writer to ensure that CDM needs are being met and that the deliverables are provided to the Sponsor according to timelines

Our Clinical Pharmacovigilance Services

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Development of Safety Management Plans
Preparation of MedWatch and CIOMS forms
Prepare supplementary documentation (SAE form, templates, etc.)
Review and management of suspected serious adverse reactions
Database setup and UAT
Individual Case Safety Report (ICSR) processing for serious adverse events (SAEs) and other events of interest
Safety database hosting

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Reconciliation with clinical database

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Eudravigilance registration (if needed)

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Cross reporting to IRBs and ethics committees

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Medical monitoring
Management of adjudication and data safety monitoring committees
Triage and tracking of cases for reportability with applicable regulatory agencies
Author or assist with periodic and summary reports including annual reports: IND, DSUR, etc.
Full case processing in ArisGlobal

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Author Intake (via the Medical Information call center)

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Expedited regulatory reporting for SUSARs
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OUR BENEFITS

Why Linical?

The clinical development journey can be daunting and often leads to failure. With so much riding on your compound, you deserve the best chance at achieving your goals and positively impacting patients across the globe.

As a global, award-winning CRO, we can provide the strategy and support you need to position your clinical trial for success. We have an impressive track record of exceeding our enrollment goals and maintaining nearly a 90% client retention rate.

With our collaborative approach and commitment to quality, Linical expertly guides you through each step of the process, from early-phase research to large-scale global studies. With Linical, you can overcome obstacles, expedite timelines, save valuable money, and achieve your goals without compromising quality.

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Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

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