ABOUT US


Ardent Clinical Research Services

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    Ardent Clinical Research Services is one of India’s leading providers of integrated clinical research services having operational facilities in Pune, MH, India. We have been successfully serving to a wide range of clientele comprising of biopharmaceutical, Herbal, Neutraceutical, Device companies and generic drug industry.

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    Our broad spectrum of superior quality services are designed to meet our customers’ specific needs. The team of experts at Ardent offers management and leadership solutions to clinical researchers to ensure that their project starts on the right foot. Apart from a timely start, an efficient execution and delivery of clinical trial projects is ascertained.

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    We’re equipped with ICH GCP, Standard Operating Procedures (SOPs) and all our clinical trial activities strictly comply with the regulatory principles and guidelines. As we conform to the highest standards of ethics, the patients under investigation can rest assured about their safety and confidentiality.

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    With our exhaustive investigator database and technical expertise in diverse areas of therapeutic research, we enable faster patient recruitment, cost-effective trials and a world-class clinical support. But what really sets us apart from our peers is our quick turnaround times and the personal attention, we pay to our customers.

DATA MANAGEMENT


Ardent Clinical Research Services provides end to end comprehensive clinical data management services to the clients from Data Management Plan to Database Lock. The team works on a robust portfolio and strives to ensure the highest quality.

Clinical Data Management Services Include :

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    Project Management.

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    CRF Completion Guidelines.

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    Data processing through double data entry.

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    Safety Data Management & Reconciliation.

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    Provide Software’s to the Hospitals.

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    Data Management Plan (DMP) development.

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    Database Build & Design.

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    Query Management.

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    Data Export/Transfer.

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    SAS Programming and statistical Analysis.

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    CRF/eCRF design and development.

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    Data validation specifications.

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    Medical Coding.

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    Support of Phase I to post-marketing trials.

Key Features of Source Transcript :

Customized & reliable Data Management for integrity, accountability & speed from database-build to database-lock by using our Own software “SOURCE TRANSCRIPT”

  • ● US FDA 21 CFR Part 11 compliant Validated System

  • ● High System Scalability

  • ● Study Documents Repository.

  • ● Customized Reporting & Dashboards

  • ● Multiple Data Extraction Formats

  • ● Randomization system set-up/IWR Randomization system

  • ● EDC/RDC or paper data-capture (e-CRF design & development)

  • ● Database set-up (design, development and validation)

  • ● Double Data-entry

  • ● Data-validation specifications

  • ● Medical Coding of events & medications

  • ● Coordinated clinical data cleaning & QC’s review

  • ● AE-reconciliations (in paper and EDC systems)

  • ● Integration and transfers of external 3rd party data

  • ● Database Lock

  • ● The application development is using ASP.NET and MS.SQL data base system

  • ● The application is hosted on a secured windows flatform with appropriate securities for access to relevant stake holders.

  • ● HostGator server which is located in Texas USA having auto back up.

Biostatistics and Programming :

  • ● Regulatory statistical consulting

  • ● Study design

  • ● Sample size estimation

  • ● Randomization scheduling

  • ● Statistical analysis plan

  • ● Statistical programming

  • ● Interim analysis support

  • ● Generation of tables, listing and figures

  • ● Provide complete support in CSR, ISS/ISE preparations