Our standards

“Quality is never an accident…” Quality in our company starts with well-trained employees and continues through in-house and on-site quality control procedures. Last but not least, quality is assured by quality assurance activities conducted also in-house and on-site. In Leading Clinical Research we never replace quality with quantity.

Our Quality Standards are defined in our Standard Operating Procedures, continuously updated documents guiding our entire staff during their everyday work.

Leading Clinical Research has also a certified Quality Management System compliant with the ISO 9001:2008 standard in the following areas of our services:

  • Conduct and organization of clinical trials on investigational products and medical devices.
  • Conduct and organization of non-interventional studies.
  • Educational courses in clinical trials on investigational products and medical devices, pharmaceutical medicine, and non-interventional studies.
  • Conduct and organization of medical writing.

Last but not least, we fully comply with the Foreign Corrupt Policy Act and any other anticorruption measures.

List of LCR’s Standard Operating Procedures:

  • Organization of Facility
  • Job descriptions
  • Training
  • Data Backup and Computer Data Security
  • Disaster
  • Handling of Sponsor’s SOPs
  • Third Party Selection Process
  • Project Management
  • Project Take/Hand over
  • Regulatory Submissions
  • Informed Consent Process
  • Translation Policy
  • Site Selection Process
  • Site Initiation Visit
  • Site Monitoring Visit
  • Site Co-Monitoring Visit
  • Site Close out Visit
  • IMP management
  • Clinical Trial Documents
  • Clinical Trial Material/Document Shipment
  • Serious Adverse Event Reporting
  • Handling of Suspected Fraud, Misconduct and Non-compliance
  • Archiving
  • Confidentiality Agreement
  • Contract with site and/or investigator for conducting clinical trial
  • Quality Management System
  • Format and Content of Clinical Trial Protocol
  • Amendments to Clinical Trial Protocol
  • Case Report Form Design
  • Format and Content of Clinical Study Report