CLINICAL CONSULTING
Clinical Trial Study Design and Protocol Development
The clinical trial protocol describes the objective, rationale, design, methodology and organization of a clinical study. Careful planning and consideration of clinical trial study design is an important step in achieving the desired primary and secondary endpoints you desire in the most cost effective and timely manner possible.
Depending on your ultimate goal, our clinical consulting team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations.
Our clinical consulting team will help develop a clinical trial protocol which includes:
- Introduction which includes general information on the sponsor and investigational device, as well as background information about why the trial is being conducted, a description of the trial purpose and objectives including a statement of primary and secondary endpoints
- The Clinical Investigational Plan which includes the following information:
- Study design, subject selection, inclusion, exclusion and withdrawal criteria
- Efficacy and safety assessments and variables
- Overview of trial procedures and methods of assessment
- Treatment administration, packaging and labeling, storage, subject assignment, disposition and compliance requirements
- Adverse Event (AE) reporting including definitions of adverse events, serious adverse events, device-related events, pregnancy, events of interest and collection and reporting requirements
- Statistical methods to be used, sample size, analysis plan, termination criteria, randomization methods, etc.
- Ethical considerations including a description of the role of the Independent Ethics Committee (IEC) or Institutional Review Board (IRB), ethical conduct of the study, subject information and consent
- Data quality assurance, source documentation and case report form completion, monitoring expectations, data handling, record keeping investigator training, audit/inspection procedures and handling of Personal Health Information (PHI)
- Investigator selection criteria, study completion procedures and reference list
- If applicable, Healthcare Utilization Information (HUI) collection and analysis procedures, customized appendices such as the Investigator Agreement, List of Abbreviations and Definitions of Terms, Informed Consent Form (ICF) template, etc.
Depending on your budget and availability of in-house resources, Emergo Group can be involved in all or part of your clinical trial study design and protocol development.
Medical Device Clinical Trial Management and Monitoring
We works with medical device manufacturers to develop medical device clinical trial protocols and manage clinical trials to ensure successful outcomes. Our worldwide medical device clinical consulting headquarters is based in Europe with available consulting teams on all major medical device markets, from US to Japan. We have worked with each individual medical device company worldwide on regulatory compliance and clinical trial management projects.
Clinical trial monitoring for medical device studies
It is the responsibility of the clinical trial sponsor to ensure the safety of patients and maintain the accuracy and consistency of data collection during the trial. Our clinical trial monitors are medical device specialists and have been fully trained in Good Clinical Practice (GCP). Our medical device clinical trial monitoring services include:
- Overseeing progress of the clinical trial to ensure the study protocol is being followed and complies with GCP and ISO 14155.
- Monitoring enrollment of qualified subjects.
- Ensuring consistency of data collection and patient treatment across multiple sites and communicating/addressing deviations from the clinical trial protocol, SOPs, GCP, etc.
- Reviewing documents to verify that reports, submissions and other documents are accurate and up to date.
- Ensuring that adverse events are reported in accordance with GCP, the protocol, Independent Ethics Committees and any regulatory mandates.
- Preparing clinical monitoring outcome reports after site visits according to established SOPs.
- Compiling final clinical study report and study master files.
Our clinical trial management teams have vast experience with a wide range of medical devices, including many high-risk cardiovascular, orthopedic and combination products. If your company has existing clinical resources, we can work with you to provide some or all of the clinical trial management services listed above. Our ultimate goal is to reduce the time your trial takes and produce a positive outcome for the lowest possible cost.
Clinical Trial Management for Medical Devices in Europe
Are you preparing to undertake a clinical trial in Europe? Do you need help with surgeon or site recruitment? Do you know what ethics committee and competent authority approvals you will require?
We offer your company all our expertise in setting up, conducting and reporting clinical trials designed for:
- Demonstrating the clinical safety and effectiveness of a medical device for CE Marking.
- Obtaining post-market surveillance clinical data on devices with CE Marking.
- Obtaining health economic data to support obtaining reimbursement approvals.
Together we will design your clinical trial with appropriate study endpoints in mind. Whether you need to collect data to support CE Marking, a scientific publication, or drive marketing awareness/acceptance, we will develop your clinical study and help you to determine the optimal number of patients and study sites, study duration and length of follow-up.
Our clinical division offers comprehensive clinical trial management services covering everything from study design and protocol preparation to management of the study, data analysis and final reporting. Members of our clinical consulting team speak English, Italian, Spanish, German and French.
Our EU clinical trial management division offers a comprehensive range of services including:
- Physician/Surgeon/Medical center recruitment.
- Study design input & review - optimization of endpoints and scoring systems.
- Identification of qualified independent third parties to conduct radiographic data analysis.
- Preparation / review of study documentation (i.e. protocol, clinical investigation brochure, case report forms, patient information letters, informed consent forms, etc.).
- Competent Authority and Ethics Committee submission and liaison.
- Database design and validation.
- Arrangement of patient insurance.
- Study monitoring (initiation visits, routine intra-study visits and close-out visits).
- Preparation of monitoring outcome reports.
- Data collation and database input.
- Data queries handling, analysis and manipulation.
- Traceability to hard copy patient records and identification of duplicate entries.
- Final report and study masterfile compilation
- Project management of the clinical study.
Our medical device clinical trial management expertise covers a range of devices, with a focus on high risk products including cardiovascular and orthopedic implants. We have conducted prospective CE Marking and post-marketing surveillance clinical studies on drug / device combinations, including drug-coated cardiovascular implants and antibiotic impregnated dressings, both of which have provided valuable insight into the ethics committee and competent authority requirements for clinical studies involving drug / device combinations.
Clinical Evaluation Reports for Medical Devices Sold in Europe
European Directive 2007/47/EC, which amends the EU Medical Devices Directive MDD 93/42/EEC (and Active Implantable Medical Devices Directive AIMDD 90/385/EEC), places greater emphasis on clinical data and a Clinical Evaluation Report. Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement "clinical data, even for Class I devices, will generally be required." Also, Annex I, Essential Requirements now states: "Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X." All the documentation must be in compliance by March 2010 to be able to promote their prduct on European Union Market.
What is clinical data?
Clinical Data is an important component of the CE Marking process. It is defined and included in Article 1.2 (k): "The safety and/or performance information that is generated from the use of a device. Clinical data are sourced from: clinical investigation(s) of the device concerned; or clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated."How can we assist with the medical device Clinical Evaluation Report?
Clinical evaluation entails the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. We are specialized in reviewing medical device clinical data, and we can ensure that your Clinical Evaluation Report meets all European requirements. We can assist you in developing a procedure to perform these Clinical Evaluation Reports or we can prepare them for you based on your procedures. If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.
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