Medical device clinical trial services
Study Concept Consultation
To support the development program and study concept, Key Personnel will assist you presenting it to Key Opinion leaders and Notified Bodies with the goal to optimize the study design within the context of standard of care; ensure feasibility; assess risks and opportunities to scientific integrity, subject protection, regulatory compliance and performance; validate the concept and propose adaptive alternatives.
Our goal is to ensure your Investigational Plan will be suitable for validation by Notified Bodies; ethically acceptable; easy to implement, effectively followed and complied with by investigational staff; adequate for subjects recruitment and retention. Physicians qualified by adequate professional clinical and research experience, and training for medical writing and records management are skilled to effectively translate the study concept into ISO 14155 compliant and comprehensive investigational plan accompanied with supporting operational and technical instructions.
Trial Site Selection
HungaroTrial presence in several and various European
countries enabled us to establish a large database of clinical sites (1500+) already demonstrating successful recruitment, excellent compliance and performance, while our reputation opens door to Key Opinion Leaders. We arrange pre-study consultations and welcome Client's active involvement in the selection process to reach mutual understanding at early stage between Client, HungaroTrial and Investigational team with regards to requirements, technical pre-requisites and expectations for trial conduct.
Clinical Trial Application
HungaroTrial established medical device regulatory intelligence system to navigate through the complex regulatory framework. Acting locally, next the source of information allows direct contact and consultation with Competent Authorities, ensures timely applications and reporting. Centralized expert review of technical documentation assures validation for submission. Coordination with project team is aligning the operative daily work with regulatory strategy to reach milestones.
Clinical Project Management
The triangle of operations, trial management and project management is the concept to maximise the potentials from knowledge, clinical research experience and functional skills of HungaroTrial medically qualified personnel. This concept assumes that our project management team is able to plan, implement, control, act, organize and communicate in the trial at different levels and functional domains, so to maintain the integrated and aligned execution of trial duties and functions within the constraints of scope, quality, budget and time, by minimizing the risk and efficient issue resolution.
Device Logistics Center
The role of Device Logistics Center (DLC) is to plan, direct, monitor, track and promptly act on issues along the supply chain troughout the lifecycle of the trial. DLC advises and support local purchase, whyle interacts with authorized and selected distributors. DLC intensively monitors critical sequences (transit time, import/export and delivery) and implementation and effectiveness of measures for safe, secure, controlled and traceable transport and storage.
Device Service Support Center
Operability of device is vital for trial quality and performance, technology being object of investigation. Device Service Support Center is ensuring consistent use of devices according to user manuals; provide product related technical and service background knowledge; facilitate communication between trial sites and clients, troubleshoot responsively, promptly and user-friendly.
Device Vigilance Management
Our goal is facilitation of timely interaction and exchange of information of regulatory relevance between Client and Authorities according to the regulation.
Depending of the stage of clinical investigation, class and type of the medical device, to unknown, known and anticipated risks HungaroTrial is capable to provide resources, organization, management and validated systems for identifying, evaluating and reporting adverse events.
Data Management and Statistics
Maintaining data integrity throughout the trial lifecycle and along development has always been critical component of regulatory assessment, and is constantly challenged by digitalization, virtualization and increasing scrutiny for security, confidentiality, protection and long term retention of clinical and personal data. HungaroTrial offers effective, validated and regulatory compliant, "from input-to output", customizable eSolutions for integrating biostatistics, design and development of Case Report Forms, data validation, analysis and reporting.
Clinical Study Report Writing
We engage medical and scientific experts, statisticians and regulatory reviewers for the scientific validity and regulatory relevance of CIR. Our skilled and experinced medical writers will ensure CIR to be prepared with the contentand in format and structure according to ISO 14155. From HungaroTrial perspective, preparation and submission of CIR is a project with defined structure, responsibilities, timelines and deliverables that is managed/coordinated by regulatory experts.