Get ready to take control of your clinical trials.
Where clinical trial challenges are met with effective solutions.
Our Services
Clinical Services
Clinical trials are major investment for companies. The return on the investment can be substantial if the trial is able to achieve its objectives. Clinical Trials can also be high risk situations when required for market access and they drive Strategic Company/Investor/Shareholder interest and value.
We start our clinical trial process by first learning the goal and objectives for the trial. We conduct a gap analysis if indicated against your current pre-clinical and clinical data, and the indications for use and/or marketing claims that you are looking to support. We evaluate the regulatory path to market access and the clinical study requirements for the target markets, relative to pharmaceuticals or medical device pathways. We investigate clinical trials conducted by others in your specific area of indication for use to assess outcome variables, number of subjects, number of sites, and likely enrollment period.
We then develop a clinical strategy and pathway to achieve your goals, respectful of both time requirements and budgets. Depending on the needs of the Client, the clinical strategy might include a Pivotal Trial for regulatory approval or start with a proof of concept leading to a small feasibility then to a pilot study then to a Pivotal Trial. A clinical pathway may also involve real world evidence or post-market clinical follow-up evaluation data. Each Client has unique requirements, and we custom develop these plans guided towards success of the Client’s specific objectives.
For large multi-national pivotal trials, we often assist Clients with large CRO selection through a request for proposal process, budget negotiation, and assistance with managing the CRO relationship and clinical trial as needed by the Client.
We also offer “fractional” Chief Medical Officer services that small start-up companies may need until they are able to hire additional personnel.
Let us know how we can help achieve your goals and objectives for clinical trials.
Quality Services
Regulated industries have moved towards using risk-based assessment to conduct business activities. For example, manufacturing companies for medical devices are generally ISO13485 certified. In the US, medical device companies will need to comply with the new QMSR requirements no later than February 2026. QMSR is based on ISO13485, but not identical to it. Therefore companies that sell in and outside the US will need to update their quality systems to address unique aspects of both. We complete gap assessments on Quality Systems and provide detailed assistance with updating SOPs and the overall QMS as needed, including setting up and initial QMS for companies and providing ongoing support if needed.
When we conduct clinical trials for medical devices, we operate under ISO14155 (2020), a risk based approach to conducting clinical trials. The recent ICH E6 Revision 3, commonly referred to “Good Clinical Practices,” likewise moved towards using a risk-based approach for conducting clinical trials for drugs. We maintain our clinical quality system through GreenLightGuru Quality systems.
Small start-up companies often do not have the need for full-time Quality personnel, and we often assist with developing initial Quality Systems, maintaining them until the need for a full-time person, and then working to train and transition over to internal resources. We often continue working with Clients, as the Chief Medical Representative to assist with management of vigilance and safety reporting requirements.
Let us know how we can help you with your Quality Management System needs.
Regulatory Services
Staying on top of regulations in varying countries can be challenging. Start-up companies often need assistance determining the regulatory pathway for market access in target markets. We assist with classification of medical devices and timelines for regulatory submissions.
Depending on the needs of each Client, we can conduct regulatory assessments and work with partners on full regulatory submissions for both drugs and medical devices.
We assist with registration in countries around the world, as well as resourcing authorized representatives, internal and external auditors, and notified bodies. We work with internal teams to develop various risk assessments as needed for their products.
We conduct training in regulatory requirements such as EU MDR. We provide medical writing services such as Clinical Evaluation Plans, Literature Reviews, Clinical Evaluation Reports (CER), Post-Market Surveillance plans and reports, Post-market clinical follow-up (PMCF) plans and reports, Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP), depending on the class of medical device.
Let us know how we can help you with your regulatory needs.
Helping Companies with Medical Research Needs
We work with companies of all sizes from small start-up companies with only 3 employees, to large multi-national pharmaceutical and medical device companies. Each Client has its own needs, and we work with the Client to determine the best pathway to obtain the clinical evidence and regulatory registration/clearance/approval needed for their specific situation.
Helping You Achieve Your Business Objectives
It all begins with an idea, maybe written on the back of a napkin at lunch one day. Let us help you bring that idea to market with compelling clinical evidence that meets regulatory requirements in your target markets.
Contact Us
Please contact us to let us know how we can help you with your medical research, clinical trial, regulatory, and quality systems needs.
