We provide customized services, which can be deployed on a stand-alone basis or as part of an integrated “full-service” solution, including study design, regulatory consultation, study monitoring, data management, biostatistics, medical writing, quality assurance, and project management. All activities will be performed in accordance with global guidelines (ICH-GCP, ISO 14155 etc.) to ensure compliance with all applicable regulations, IRB or EC policies and protocol requirements.

Clinical Operation

Bestat offers various types of activities for clinical studies depending on customer’s requirements. Our dedicated clinical research team is supported by clinical research associates, project managers and regulatory affairs who are assigned to set up activities for clinical studies, track the study timeline and budget as well as assist in communication with regulatory bodies, study submission and marketing authorization application.

The services we provide include
  • Clinical Research Activities
    Site qualification assessment
    Study site set-up (Site initiation visit)
    Source data verification
    Study site close-out
    Investigational product management
    Site personnel training
    AE reporting (including SAE and SUSAR)
  • Project Management
    Study timeline set-up and follow-up
    Budget estimate and manage
    Study status tracking and report
    Risk management
  • Regulatory Consultation
    IND submission
    NDA application
    Strategic & Regulatory affairs consulting
    Submission package preparation

Medical Service

Bestat medical team is supported by a group of medical consultants in different therapeutic areas and our medical writers hold PhD or Master degrees in clinical related fields. Not only being experienced in study design or medical writing, our medical writers are also certified coders for adverse events by MedDRA. The team is dedicated to provide professional opinions in various aspects of clinical research and studies.

The services we provide include
  • Medical Writing
    Protocol design
    Investigator’s brochure preparation
    Informed consent form development
    Clinical study report generation
    Scientific, conference articles or posters supports
  • Bridging study evaluation
    File compiling
    BSE application

Data Management and Statistics

Data management and statistics are crucial steps in obtaining integrity and credible data and analysis results. Bestat’s Data Management and Statistics team is supervised by statistical consultants with over a decade of experience in statistics and clinical studies. We provide customized data management service to meet customer’s needs via electronic data capture (EDC) system or paper format case report form alone with in-house database development and management.
The team members hold SAS certifications, possess strong abilities to perform statistical analysis, programming, database design and are able to give professional advice on statistical methods in the study protocol.

The services we provide include
  • Data Management
    CRF design
    Database set up (EDC or paper based)
    Data clarification
    Data validation
    Data clean and lock
  • Statistics service
    Randomization code generation
    Sample size calculation
    SAS programming
    Clinical data analysis
    Interim analysis
    Data mining
    Healthcare data analysis
    Data listing

Quality Assurance

Bestat independent quality assurance team is dedicated to offer quality audit and assurance services in order to assess whether the studies conducted by Bestat meet the applicable regulations, GxP, IRB or EC policies and SOPs. The activities conducted by the quality assurance team help to improve the study quality and to correct any discrepancies observed during the study period. Our quality assurance team is staffed with experienced personnel in different study phases and indications.

The services we provide include
  • Audit
    Internal audit
    On-site audit
    FDA inspection preparation
    Vendor selection and qualification
    Vendor selection and qualification

Clinical Event Committee

For some clinical studies, an independent clinical event committee (CEC) is necessary to ensure the integrity and accuracy of the collected data, to assess whether the specific endpoint meets the protocol requirement, to review the safety events, and to provide recommendations on the continuation of the study in a timely manner. At Bestat, we offer different type of CEC consisting of experts acknowledged in specific fields according to customer’s needs, protocol and regulatory authority’s request if any.

The services we provide include
  • Dose escalation committee (DEC)
    Data and safety monitoring board (DSMB)
    Independent review committee (IRC)
  • Pharmacovigilance service (PV service)
    Customized PV database
    Signal detection
    Adverse event coding
    Safety report generation