Our Services

Clinical

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.

Depending on the needs of the Client, we can develop a clinical strategy, develop a gap analysis for clinical data needed for regulatory registration/approval, conduct clinical trials or manage a larger CRO for large, multi-national clinical studies.

  • We start our clinical trial process by first learning the goals 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.

Regulatory

Staying on top of regulations in varying countries can be challenging. We can assist with training as well as development of required documentation. We provide regulatory submission and medical writing services such as Clinical Evaluation Plans, Literature Reviews, Clinical Evaluation Reports, Post-Market Surveillance, and Periodic Safety Update Reports.

  • 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.

Quality

We work with multiple partners, including Greenlight Guru, to help companies develop and maintain Quality Systems that meet requirements and pass internal and external audits. 

  • 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.

We partner with Greenlight Guru for our Quality Services