The Research Physician is a key member of any drug development team and forms the backbone for all medical and scientific aspects of clinical research projects. We provide scientific and medical input to all aspects of clinical studies and development programs from concept to conclusion.
Europital’s Medical Monitors form a scientific driving force behind all study phases with 24/7 medical guidance provided to investigational sites and the various study teams to ensure patient safety and scientific integrity of the study. Our Research Physicians perform expert medical review of clinical and safety study documents, the accumulated data and associated reports to ensure the quality of the study, the robustness of the data and the scientific value of the conclusions.
Physician-to-Physician scientific interactions are essential to establish a reliable partnership between Investigators and Sponsors. Europital medical liaisons ensure continuous site engagement via scientific interactions with investigators and site staff that facilitate essential knowledge transfer and resolving of potential obstacles that might impact the study.
- Medical Expertise from concept to conclusion
- 24/7 Medical Monitoring
- Medical Review of documents and data
- Medical Liaison and site engagement
- Medical and Scientific Training
Scientific and Medical Guidance
|1.||Investigational site requests guidance||4.||Monitor requests guidance from Responsible Team||A.||Answer found in existing project-specific knowledge base|
|2.||Monitor consults project-specific knowledge base||5.||Digital round-table team deliberates to establish guidance||B.||Answer provides to monitor & knowledge base is updated|
|3.||Monitor searches established answer & guidance documents||C.||Monitor provides requested guidance to site|
Interactive Guidance Management System (IGMS)
An important service of Medical Affairs is providing scientific and medical guidance. Through an intuitive interface, our Interactive Guidance Management System (IGMS) PenThu® enables responsible physicians and study leads the means to smoothly provide medical and scientific guidance to the wider study teams across multiple projects with minimal effort, saving; time, energy and resources. Medical questions and guidance requests are automatically processed and managed in the IGMS via its interactive dashboard in a digital roundtable environment. The delivered guidance is automatically and instantly made available for the entire team via both online search and a formatted, downloadable Q&A Log.
Our IGMS provides start-to-finish guidance data capture with powerful tools for creating a project-specific knowledge base, in addition to full documentation of guidance processing, issue handling and decision making. With the integrated metrics, analytics and KPIs, the IGMS facilitates issue resolution, informated decision making and CAPA.
The vital roles of the Clinical Operations team ensure timely and efficient planning, execution and conclusion of each clinical trial.
By combining science and state-of-the-art technologies, Europital optimizes each step in the clinical trial process whilst maintaining the highest regulatory standards, the safety of the patients and scientific integrity of the data collected.
Our seasoned project managers utilize their technology management capabilities to integrate the most advanced clinical research technologies in the daily clinical trial operations to ensure quality and efficiency.
With its broad experience in drug development and clinical research in various therapeutic areas and disease indications, Europital project management team ensures appropriate planning, efficient execution, and timely conclusion of your clinical project.
We adopt an agile management approach with the expert Core Team assigned to each project, assuming full responsibility of organization and execution of the project together with guidance, coordination and supervision of regional and local operation teams.
Europital Project Managers are the driving force for all cross-functional activities in our projects:
- Primary point of contact to sponsor
- Project planning and implementation with full oversight and coordination of various activities
- Ensuring compliance with ICH-GCP, applicable regulations and SOPs, and the study protocol
- Recruitment and retention strategies
- Grant and Vendor Management
- Technology Management, such as CTMS, EDC, IWRS, CTSU, IGMS
- Management of Trial Master File
- Management of Budget and Payments
- Risk assessment and CAPA
Clinical monitoring is an inevitable quality control process that happens before, during and after a trial is conducted. Essentially, clinical monitors have the responsibility of checking that the protocol is being followed by investigational sites and thereby ensure the integrity of the trial data being recorded and the protection of the study participant’s wellbeing. The monitor performs a range of activities to verify that the study is being performed well and to report this information to Project Management, with suggestions for CAPA.
Beside their monitoring experience in various therapeutic areas and disease indications, and the continuous support by the Europital study management team, all monitors at Europital have the scientific background and clinical training that enables them to manage the particular requirements of each study.
- Feasibility and Site Identification
- Site Initiation and Management
- Study Monitoring: onsite visits, virtual, remote and wearables
- Site communication and project-specific training
- Accountability for sites’ study documents and materials
Optimal data management, programing and statistical analyses processes are pivotal to reducing the time and cost of drug development. The improvements that can be made by implementing the most appropriate and advanced measures available for designing, collecting, analyzing, converting, and reporting clinical research data throughout the drug development process result in an objectively higher data quality. Our biometric services provide submission-ready trial results with an assurance of scientific integrity.
From trial design to clinical trial reporting, Biostatistics play an indispensable role in the clinical development process. At Europital, we provide a modular approach adapted to the specific needs of your project. We provide experts in the biostatistics fields for trials from Phase I–IV and from providing advice on a single issue through to statistical coverage for an entire project from concept to regulatory submission and defense.
- Statistical input to protocols, including overall strategy and sample size calculation
- Preparation of the Statistical Analysis Plan (SAP)
- Adaptive design and group sequential strategies
- Innovative analyses, such as Lag-time analysis
- Interim analyses and Exploratory post-hoc analyses
- Full integration of CDISC
- Preparation of DSMB charters and analyses, and Participation in DSMBs as independent statisticians
- Participation in Regulatory Agency Meetings as the responsible statistician
- Performance of analyses and reviewing or preparing answers to Regulatory Agency questions
- Consulting, planning, preparation, and review of the Integrated summary of safety (ISS), the Integrated Summary of Efficacy (ISE), and the clinical pharmacology summary
- Post-marketing and lifecycle management activities
Rigorous and comprehensive Clinical Data Management is critical for the success of clinical trials. To ensure your trial generates high quality, scientifically valid and statistically sound data, our experienced data managers can be part of your clinical development strategy and reliably increase your trial capabilities from the planning stage, through to execution and beyond.
Europital provides well performing data management expertise and secure technology. Our data managers have a scientifically driven mindset with a view to collaborating with cross functional teams to ensure that data is collected, managed and reported accurately and so reduce the development time for new treatments.
- Clinical database design, testing, and implementation
- Development of the data management plan and data validation plan
- Case report form (CRF) design either with electronic data capture (EDC) or paper
- Medical coding
- Data entry and Data review
- SAE reconciliation and Discrepancy management
- Oversight, management, uploading and review of third-party data
- Database lock activities
Regulatory affairs provide strategic, tactical and operational direction to ensure compliance with applicable regulations to expedite the development and delivery of safe and effective products.
By optimally planning and implementing appropriate and tailored regulatory strategies for your clinical development plan, Europital can lead you through successful interactions with authorities and accelerate your product towards approval.
- Strategic Consulting
- Development plans
- Dossier Submission
- Integrated analysis plans
- Dictionary coding and recoding for consistency
- ISS and ISE creation
- Regulatory Document Writing, including: Dossier Content, Annual Reports, IMPDs
- eCTD preparation, publishing and submitting through electronic portals
- NDA, BLA, MAA writing, compilation and submission
- Preparation, Management, and Submission of Regulatory Dossiers (INDs, CTAs, MAA, BLAs, and NDAs)
- Strategic guidance and support for FDA and EMA meetings
- Gap Analysis of Regulatory Data
- Drug Development Plans
- Pediatric Development Plans
- Regulatory Filing Strategies and Designation Requests, such as Orphan, Fast-Track and Breakthrough
- Facilitate and attend agency and scientific Advice Meetings
The monitoring, detection, collection, assessment and prevention of adverse effects of pharmaceutical products and Medical Devices are essential elements to ensure patients’ safety and wellbeing.
The Europital team of Pharmacovigilance (PV) scientists together with our safety physicians support Pharmaceutical, Biotech and Medical Device companies to ensure patients’ safety and meet regulatory requirements via the appropriate setup and implementation of all aspects of PV.
- Setup, Managing and Maintaining Safety Database
- Adverse Event management and expedited reporting
- ICSR Processing and Reporting
- Aggregate Safety Reports preparation and submission
- Literature Search
- Risk Management
- Eudravigilance setup, registration and reporting
- EU QPPV
- Pharmacovigilance System Master File Management
- Medical Device Vigilance
Europital’s medical writing expertise can provide you with a significant advantage when it comes to communicating the efficacy and safety of study treatments. Throughout the drug, and medical device, development processes everybody involved needs to know whether the products they are researching are safe and effective.
Europital’s medical writers can manage projects efficiently and provide a clear and logical account of studies to assist you in your efforts to communicate these key messages throughout the initial registration and clinical trial cycle and beyond.
Clinical Regulatory Documents (Phase I – IV)
There are many clinical regulatory documents that need to be written throughout the lifecycle of an investigational medicinal product. In each of these, it is necessary to collate the safety and efficacy data that has accrued, analyze them and explain the results clearly. To achieve this, Europital’s experienced medical writers recognise that it is essential to know both the purpose and intended audience of each document.
The audiences for these clinical documents can be regulatory authorities, medical professionals or patients and, as these documents are a presentation of complex scientific and regulatory information, they must be written in a manner that is both logical and easily understood by the people for whom they are intended.
- Clinical Study Protocol
- Clinical Study Report (CSR)
- Patient and Safety Narratives
- Investigator Brochure (IB)
- Clinical Development Plan
- Standard Operating Procedures (SOP)
- Investigational Medicinal Product Dossier (IMPD)
- Common Technical Document (CTD) Modules
- Product Monographs
- Product Labelling
- Summary of Product Characteristics (SmPC)
Medical Device Documents
As medical device regulations and guidelines become more stringent, the need for effective medical writing skills also becomes increasingly important. Europital’s writers have the relevant skills to source the required data concerning R&D, clinical, quality, safety, regulatory, sales, marketing, risk management and manufacturing. Experienced in analyzing complex data and compiling detailed plans, evaluations and reports according to regulatory stipulations, our medical writers are sure to become key members of your authorship team and play a central role in giving your device’s the best chance of success for regulatory compliance.
- Clinical evaluation reports (CERs)
- Post-market surveillance plans
- Post-market surveillance reports
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Summary of safety and clinical performance (SSCP)
Medical and Healthcare Communication Documents
In order to share useful research findings with the global community, the publication of clinical trial results need to be reported in a high quality, comprehensive and timely manner. Europital’s medical writing specialists can help reduce the time from Last Patient Last Visit to primary publication and also to help you communicate your message in a variety of media to a variety of audiences.
Whether aiming to reach scientific and medical professionals, industry peers, or the prospective patient or study participant, Europital can assist in crafting your key messages into the appropriate readability level, desired style, format and design for better engagement with your target audience.
- Primary Publications
- Reviews and book chapters
- Event documentation for Expert Meetings and more
- Conference and congress abstracts and posters
- Slide kits
- SEO-optimized website content and online articles
- Patient information and self-help resources
- Medical education and training media