Audit readiness for FDA, HHS, OCR, CMS/Medicare. Training and expertise: FDA regulations, HITECH Act, HIPAA and OCR Enforcement Audit Preparation, ICH regulations
Objective Clinical will assist with implementing the research infrastructure of policies, procedures and ongoing process management to ensure regulatory compliance. By establishing a formal set of guiding procedures, coupled with awareness and training for your staff, regulatory compliance will become a key element of the culture of your organization. This research culture framework will significantly reduce risk and the likelihood of regulatory violation while enhancing the safety of your subjects.
- FDA, HIPAA, HITECH, HHS, OCR, and ICH research regulation and data compliance
- Develop policies and standard operating procedures for research
- Harmonization of policies and procedures across a network of sites
- Enhance subject understanding and safety
- Implement solutions to store and track key research records
- Ensure charging and billing for research complies with CMS and other regulations
Objective Clinical works with the sites to develop a research quality culture. We will help you to establish a quality program with templated policies and procedures.
- Quality program for research
- Risk reduction from regulatory non-compliance
- Routine internal audit for assurance and regulatory diligence requirements
- System checks for proper data transmission, storage, and retention
Objective can provide legal services with lawyers with a focus and expertise in FDA and HIPAA or related subject protect regulations for the conducting clinical research, data storage, data transmission, and data compliance.
- Fair Market Valuations for Physician or Provider Agreements
- Physician Management Services Agreements
- Informed Consent Template and Clinical Trials Agreements Compliance
- Breach Notification Rule Compliance