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Quality & Regulatory

Bioclinica is committed to delivering products and services that are of the highest quality standards meeting the regulatory requirements and expectations of our customers and regulatory agencies worldwide while simultaneously remaining on the cutting edge of technological advancement within our industry.  An important aspect of our quality program is working with our customers to define their needs and to ensure the delivery of clean, evidence-based decision-ready clinical research study and post-marketing safety data.

Quality Management System

Bioclinica has developed and maintains a Quality Management System (QMS) with quality efforts overseen by senior leaders from across the organization supported by policies, procedures and processes designed to ensure strategic goals are met for regulatory compliance and quality. Bioclinica adopts the following seven quality management principles: Leadership, Engagement of People, Customer Focus, Process Approach, Relationship Management, Evidence-Based Decision-Making, and Continuous Improvement.

Regulatory Engagement

Bioclinica proactively engages with health authorities and precompetitive industry committees to provide stakeholder feedback on guidance and regulation development. Bioclinica is an industry leader in regulatory intelligence and awareness and adopts practices to align its standards to our ever-advancing regulatory environment. 

Inspection Experience

Bioclinica has extensive experience supporting inspection activity with readiness, hosting and external inspection solutions to support your pre-approval inspection. 

  • Experienced working with multiple regulatory authorities in multiple regions
  • 50+ Regulatory Inspections supported in the last 5 years, including: FDA (US), EMA (EU), MHRA (UK), Health Canada, NMPA (China), PMDA (Japan), MFDS (Korea) 
  • Experienced in supporting Site, Sponsor or CRO inspection activity, remotely or on-site if requested.  
  • Experienced in addressing regulator concerns appropriately and in a timely fashion. 
  • Bioclinica has undergone a 21 CFR Part 11 predicate rule FDA inspection. It was noted that Bioclinica maintains strong compliant solutions and has adopted robust Part 11 practices

SOC Certification

System and Organization Controls (SOC) are developed to validate internal controls encompassing development, delivery, and security.  They assess the extent to which a vendor complies with the five trust principles based on the systems and processes in place. 

  1. Security
  2. Availability
  3. Processing integrity
  4. Confidentiality
  5. Privacy

Bioclinica maintains SOC 1 & SOC 2 Type 1 certification and is recertified annually.

Data Privacy Compliance

Bioclinica is committed to advancing clinical development with technology-enabled services, powered by science with a focus on compliance to international regulations and guidance.  The protection of personal data is fundamental to the trust Bioclinica customers have given us when choosing our products and services.

Bioclinica supports the entire clinical trial ecosystem with data privacy compliance.  Bioclinica has a mature data privacy office supported by its Data Protection Officer (DPO) with a PhD in data protection law and has established Binding Corporate Rules, which are data protection policies for transfers of personal data outside the EU.

Data privacy laws requires companies to control management of personally identifiable information and its governance.  In the Clinical Research sector this has long been vital for the success of clinical drug development, so it is not a pivotal change to how companies work.  Instead companies need to ensure that their internal policies are aligned with the provisions defined in data protection regulation.  Bioclinica is an industry leader in support of regulatory intelligence, understands these requirements and can support your clinical trial while maintaining compliance to global data privacy and participant confidentiality requirements.

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