Frestedt Incorporated provides clinical, regulatory, quality and engineering support.
CLINICAL SUPPORT SERVICES
Frestedt Incorporated provides end-to-end clinical research support services to ensure your research delivers results.
Frestedt Incorporated has a small team of knowledgeable industry professionals who can help to support all aspects of your clinical research operations including preparation, initiation, conduct, monitoring and close-out of clinical trials and other research projects. We have experience supporting pharmaceutical, medical device, combination therapy, food and nutraceutical research. In addition, Frestedt Incorporated has technical writing expertise and we are excited to deliver well-constructed, high quality clinical documents including Clinical Safety Reports, Clinical Evidence Reports, Literature Reviews, Post-Market Surveilance plans, Pharmacovigilance Reports and many other types of required clinical documents.
Frestedt Incorporated can support your Clinical Trial Execution functions from planning to close-out:
- Feasibility Assessment: Analyze proposed trial in relation to study design, available study population,demographics and proposed site capabilities
- Comprehensive Literature Review: Search for published research on competitive and related products as well as past sponsor research and provide a comprehensive, unbiased report
- Trial budgets: Develop overall trial budget and site-specific negotiation tools
- Protocol Development: Create protocol synopses and comprehensive protocols with evaluation of trial design
- Study Documents: Craft all documents needed for seamless clinical trial execution
- Investigator/Site Selection: Identify and qualify investigators and sites with optimal backgrounds and experiences in your therapeutic area
- Sponsor/Contract Research Organization (CRO) Training: Develop on-site or virtual training materials
- Training: Conduct on-site or virtual training for internal or external personnel on any facet of clinical research and/or specific trial requirements
- Institutional Review Board (IRB) Support: Evaluate IRB submissions and turn-around times, submit and track approvals, suggest modifications to meet IRB requirements and to expedite approvals
- Activation: Support site activation process upon IRB approvals
- Trial Registration: Facilitate registration/s including account creation on clinicaltrials.gov or other public clinical trial or registry databases internationally
- Site Management: Conduct research activities at medical provider sites (with appropriate provisions and approvals) and manage all study activities
- Monitor Management (on-site and remote): Oversee and provide monitoring visits to research sites per monitoring plan to evaluate protocol compliance as well as case report form (CRF) versus source documentation
- Data Management/Biostatistics: Manage research data and biostatistical analyses
- Adverse Event (AE) Report Management: Submit required AE reports and analyze reported events
- Closure Management: Oversee and provide activities related to site closures and obtain all final study documentation
- Report Management: Compile study documents, analyze and provide a comprehensive written final study report
Frestedt Incorporated also supports specific European Medical Device Regulatory requirements (EU MDR 2017/745 and 746) to ensure our client companies have compliant clinical support documentation. Trust Frestedt to deliver MDD (Medical Device Directive) and MDR (Medical Device Regulation) compliant Clinical Evaluation Plans/Reports, Post-Market Clinical Follow-Up Plans/Reports, Post-Market Surveillance and Summary of Safety and Clinical Performance Plans/Reports as well as many other reports required for compliant product development program
Clinical Research Case Studies
Mid-sized medical device company required CER to remediate Notified Body findings.
- Reviewed documentation and conducted systematic literature searches
- Integrated findings and trained in-house staff to create suitable reports and templates
- Managed client costs by allocating appropriate expert resources at each level of the CER development process
CER completed and staff members trained. Notified Body cleared CER without further remediation. Working relationship established with Frestedt Incorporated to conduct several other projects in client’s clinical, quality and regulatory departments.
The IRB determined a small company’s clinical trial did not meet regulatory requirements.
- Provided appropriate risk-based monitoring plan
- Received IRB approval
- Trained study staff
- Completed risk-based monitoring and advised changes to company’s Quality Management System (plan, work instructions, forms)
The clinical trial issues were resolved in a timely manner with good clinical practices (GCP) in place for future clinical endeavors.
REGULATORY SUPPORT SERVICES
Regulatory support services from submission planning and document development to regulatory authority negotiation and issue resolution to get your product to market.
Frestedt Incorporated plans, creates, develops and oversees critical regulatory activities in compliance with company policies, as well as local, United States and international regulations.
We listen carefully as we develop your comprehensive regulatory strategy. This strategy targets your specific geographic markets and marketing timelines to ensure regulatory requirements are met prior to launch in each country.
Frestedt Incorporated has compiled research materials, prepared submission documents and corresponded with regulatory authorities in many parts of the world.
Regulatory Body Negotiations
We are often asked to interact with regulatory authorities regarding regulatory strategies and “least burdensome” approaches for our clients. We respond to inquiries, schedule meetings and briefings and develop any needed correspondence documents including amendments and briefing packets.
Medical writing and regulatory work go hand in hand. Whether designing a regulatory strategy or completing a few documents, Frestedt Incorporated has hands-on experience with regulatory bodies around the world including submissions and face-to-face interactions. We can help your team focus on key priorities for submissions and we will stay on task to ensure all agency requirements are met. Our intention is to arm you with comprehensive, submission-ready information and documentation to set you on a course for regulatory approval. From planning and writing to completing required submissions, we work from ideation through post market surveillance and obsolescence. We deliver consistent messaging reinforced by data.
- IDE, IND
- Regulatory Plans
- Clinical Evaluation Plans, Reports
- Post Market Surveillance Plans, Reports
- Periodic Safety and Clinical Performance
- Summary of Safety and Clinical Performance
- Periodic Adverse Drug Experience Reports
- Periodic Benefit Risk Evaluation Report
- Periodic Safety Update Reports
- Literature Searches, Abstraction and Reviews
- Clinical Trial Documentation and Registration
- Product Labeling
- OTC Drug Label Registration
- Preclinical Reports and Summaries
- Pharmcokinetic, Pharmacodynamic Studies
- Toxicology Analysis
- ADME, Including Drug Interactions and Toxicokinetics
Regulatory Affairs Case Studies
Start-up pharmaceutical company needed regulatory support and US FDA approval to bring a drug to market.
- Formulated and negotiated generic drug regulatory strategy for 505(b)(2) submission
- Devised novel combination regulatory product plan to limit testing for kitted products
- Obtained data from competing companies manufacturing the same drug/device combination product
- Updated and trained in-house staff on quality system improvements, including new device testing requirements
- Marketed a new convenience kit
Frestedt Incorporated provided both in-house and virtual regulatory support/strategy to successfully bring generic drug and convenience kits to market — one of the first product approvals for a combination drug/device manufactured by competing companies.
Hospital supply company needed a non-sterile version of approved sterile devices, but lacked medical device regulatory experience.
- Set regulatory strategy
- Worked with the company to update design records
- Created essential labeling review processes and labeling
- Assisted with packaging changes and testing
- Avoided costly technical changes to device
- Performed risk analyses on changes made
- Recommended strategies to complete development and launch ahead of schedule
Frestedt Incorporated submitted Special 510(k) to FDA ahead of deadline, and secured clearance (without questions) for highest priority products. Also, trained company’s newly hired regulatory staff and device design teams to meet regulatory requirements.
Large medical device firm needed assistance with world-wide governmental approvals to introduce a new device to the market, to develop clinical evidence and risk documentation and to create world-wide regulatory submission strategies and documents.
- Integrated with team and executed regulatory strategy
- Worked with internal writing, engineering and international regulatory groups to develop CERs, risk management reports, manuals/IFUs, regulatory submissions, etc.
- Provided training and ensured required regulatory submission components met international standards and regulatory requirements
Projects are ongoing after over several years with multiple regulatory interactions. Training and development is impacting all departments associated with these projects.
QUALITY SUPPORT SERVICES
Comprehensive Quality Management Support
Having a robust, yet user-friendly set of standard operating procedures with supporting documents is a fundamental necessity for any company. Frestedt Incorporated remains current with US and international regulations and will analyze your current system, identify gaps and create appropriate quality documents to fill the gaps.
Quality Management System
We can help you develop quality manuals, standard operating procedures, work instructions, forms, templates and checklists.
We can provide training on upcoming or new US or International regulations, standards or guidance documents.
We can conduct quality systems audits, analyze gaps and provide guidance on quality system improvements.
We can create risk management plans and reports, conduct or review risk assessments, determine gaps and recommend improvements.
Quality Systems Case Studies
Client needed QMS oversight to support overall improvements and upcoming audits.
- Used combination on-site and virtual support methods for all audits, team meetings and training sessions
- Completed pre-audit paperwork, preparations and identified potential audit findings
- Created an action plan
- Developed an improved QMS (document revisions compliant with regulations)
- Updated the approval process and conducted interactive trainings
Frestedt Incorporated developed the QMS to reflect current working practices and to meet regulatory requirements as well as customer needs. We developed two quality manuals, 20 SOPs, 5 detailed work instructions and more than 30 templates, forms and checklists. Over several years, we conducted internal and external audits and we supported more than 8 external client assessments/audits in a 6 month period.
Start up active implantable medical device (AIMD) manufacturer needed development of a QMS to control conduct of an international clinical trial, managed through a CRO.
- Created quality documents for CRO/vender management
- Created a quality system to support clinical manager role and responsibilities
- Trained clinical manager and senior management on QMS
Client successfully launched clinical trial and re-hired Frestedt Incorporated to modify QMS as they brought CRO functions in house.
Midsize class II device manufacturer needed risk management quality support and recall advice.
- Updated SOPs, WIs and templates to ensure ISO 14971 compliance
- Trained team and implemented the new quality system components
- Also supported a class III recall for a device dysfunction
Frestedt Incorporated continues as the quality and regulatory support for this company. Company is fully operational with an active and successful updated Risk Management program in place.
BIOMEDICAL ENGINEERING SERVICES
Frestedt Incorporated provides support services to ensure your processes are properly validated and inspected to meet required standards.
The final product is only as good as the weakest parts. From strategic advice to project planning and individual processes, Frestedt Incorporated may be able to help. Our experience working on pharmaceuticals, medical devices, combination products, foods and nutraceutical products gives us a unique perspective to ensure your project is engineered appropriately while bringing in creative, high-quality solutions, as needed.
Engineering Files and Testing
- Create technical and design history files
- Verify and validate test methods
- Conduct process validations
Unique Device Identification Support
Recommend product marking
Review and suggest labeling improvements
Review risk remediation efforts, identify gaps and recommend improvements
Organize planning activities
Develop Gantt charts and manage projects
Lead and/or support teams
Biomedical Engineering Case Studies
Medical device class II low risk manufacturer was updating labeling per UDI regulations and called on Frestedt Incorporated to train and project manage implementation of the new UDI labeling systems.
- Provided training in partnership with subject matter experts
- Created project plan and tracking efforts for cross function teams to meet the required deadline
- Engaged vendors and supported vendor management activities
- Selected needed equipment (e.g., bar code verification systems) to meet regulations set by accredited issuing agencies and regulatory authorities
Frestedt Incorporated provided all necessary equipment, documentation and training to allow the client meet UDI regulations.
Client was transferring manufacture sites and customers asked for verification and validation activities to ensure the transfer resulted in quality products.
- Reviewed and updated manufacturing procedures during manufacturing transitions
- Reviewed internal validation procedures and developed validation test methods to assess finished product performance
- Reviewed associated production test methods
- Completed requested procedures and delivered documents ahead of schedule
Frestedt Incorporated delivered several test method validation protocols to the client using their development process to ensure continuation of their practices within their QMS. All documentation was reviewed and provided to the client in compliance with all parts of the clients internal QMS.
One of the largest medical device companies in the world hired Frestedt Incorporated to provide engineering support for an FDA submission to ensure technical aspects of IFU and labeling met engineering requirements.
- Reviewed and revised 25+ documents through client review cycles
- Reviewed governing standards in conjunction with specification documents
- Provided comments to ensure accurate technical specifications
Engineering support continues to ensure technical aspects are not overlooked as regulations change.