Data Analytics, Safety, and Compliance

There is a vast amount of data points on your product’s path to market. They need to be analyzed diligently, quickly, and according to MedTech regulation, but you don’t have the necessary expertise, manpower, system, or tools to do this in house, and you don’t have the time, budget, or patience for dealing with multiple service providers.

When you need knowledge, agility, and tenacity to advance your product’s data analytics, safety, and compliance, It Takes Avania.

Partner With MedTech Regulation Specialists

An all-in-one solution, Data Analytics, Safety, and Compliance provides a global workforce, advanced systems and tools, deep experience, and unmatched skill to aid you in data analytics, biostatistics, safety management, regulatory and medical writing, and more.

Our engaged and motivated team is made up of M.S., MPH, and Ph.D. level statisticians and medically experienced Ph.D. scientists organized into a flexible, easily scalable model that supports quick collaboration. Each expert is continuously trained in new MedTech regulations and tools to proactively provide customized solutions for your data needs.

If you want to work with the latest systems but you don’t have access, resources, or experience, we’ve got you covered. If you’re looking for bold, bright ideas but don’t know the ins and outs of MedTech regulation or processes, our team is here to help. If you’re on a tight deadline and need global staff working around the clock, consider it done.

We live and breathe MedTech, and we can’t wait to put that passion to work for your product.

Customizable MedTech Compliance Services

Data Analytics, Safety, and Compliance provides flexible, scalable solutions to optimize efficiencies and streamline the advancement of your MedTech product.

A vital part of your trial clinical trial team, experienced and adaptable analysts expedite timelines and decisions while ensuring your data are well-structured, clean, and in the correct format to support the claims in your clinical study report.

Committed to delivering within set timelines, we routinely accomplish clean database lock within days of the patient’s last visit.

Data visualization and reporting
- One central location for all your study data
- Customized study dashboards in easy to understand, easy to use formats
- Current summaries of study metrics, including patient variability and safety signal detection, and key site metrics like enrollment, query resolution, CRF completion, protocol deviations, and screen failures per inclusion/exclusion criteria
- Crosstab filtering for efficient current project overview
- Site startup status metrics to accelerate activities and monitor progress
- Enrollment tracking against projected enrollment to gauge study and site progress
- Safety reporting tools to review outcomes in real time
CRF
Database build
Set up integrated database workflows and modules for additional data procedures (adjudication, site payments, RTMS, etc.)
Data review and cleaning
CDISC, CDASH, and SDTM data standardization
Data integration with application programming interface (API)
Database lock
Medical coding
Data entry

Download Our Data Analytics Fact Sheet

Our biostatisticians have an in-depth understanding of regulatory and clinical requirements, uniquely enabling them to apply technical statistical and research principles that help you make better business decisions:

Pre-clinical and clinical program consultation
Sample size analysis and justification
Statistical analysis plan (SAP) development and protocol design consultation
Study design and statistical representation at meetings with regulatory agencies
Randomization schemes
Data monitoring committee (DMC) or data safety monitoring board (DSMB) statistical report generation
Generation of statistical summary tables, graphs, and reports using industry standard software for regulatory submissions, presentations, and publications
Interim and final statistical analysis and reporting, including safety and ad hoc reporting
CDISC standardization including SDTM and ADaM generation, as well as associated documentation required for regulatory submissions
Data interpretation and contribution to medical writing deliverables

Clinical experts distill and disseminate essential information while helping you design a clinical safety management plan that will efficiently bring your product to market:

Medical monitoring
- Avania-provided M.D. and support staff give expert medical knowledge that ensures proper protocol execution
- Avania experts can work with an external medical monitor
Safety management
- Therapeutically aligned experts conduct unbiased and independent endpoint and safety data reviews as well as:
  - Medical safety review
  - Review of all serious adverse events (SAEs), reporting of unanticipated device effects (UADEs), and suspected unanticipated serious adverse events (SUSARs), as required
  - Safety narratives
  - Regulatory dictionary coding, report preparation, and submission
Study oversight
- An Avania expert forms and manages Study Oversight Committees, including Clinical Events Committees (CECs) and Data Monitoring Committees (DMCs)
Clinical Events Committee
- Member selection and qualification using Avania’s access to a global pool of board-certified physicians
- Member contract and payment management
- HCP reporting preparation
- Charter and process development
- Committee oversight and management
- Serve as primary liaison between sponsor and committee, as required
Data Monitoring Committee
- Member selection and qualification
- Identify DMC members from a pool of board-certified physicians and key opinion leaders
- Administer member contracts
- Charter and process development
- Committee oversight and management
- Serve as primary liaison between sponsor and committee, as required

Whether you’re looking to enter a new market, stay compliant post-approval, evaluate transition plans from Medical Device Directive (MDD) to Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), or expand on indications, our MedTech regulation experts deliver efficient and effective strategies that support your product’s entire life cycle:

Medical writing
- Experienced, therapeutically aligned certified medical writers compile, organize, write, edit, and produce documentation for:
  - Study design
  - Post-market surveillance and clinical follow-up
  - Clinical evaluation
  - Study results reporting
  - Scientific literature
  - Investigator’s brochure
- Available as part of your comprehensive program or as stand-alone assignments
Transitioning from MDD to EU MDR and IVDR
FDA regulatory strategy
European regulatory strategy
Australian Therapeutic Goods Administration regulatory strategy
Submission strategy and support
Submission drafting
PMCF plans and reports services
Post-approval compliance/post-market surveillance
International registration
Management of product complaints per ISO 13485 and ISO 9001
Corrective actions and product recalls