Assign

Medical Devices

The regulatory landscape for medical devices and clinical trials involving medical devices is evolving in most countries. Increasingly stringent requirements have seen a rise in the number of trials subject to external audits and inspections, with the competent authorities not always returning a favorable assessment. While medical device trials resemble medicinal product trials in some ways, there are substantial differences which need to be considered.

ASSIGN has established a dedicated medical devices clinical trial group to provide you with expert support to navigate these challenges. We will help you adhere to regulatory requirements, reduce your development time and financial investments, thereby giving your product the best chance of commercial and therapeutic success.

Through continuous training and development of our staff, we can ensure that we are up to date on the latest requirements and guidelines, so you know your product and it’s development are in safe hands.

If you are planning to conduct a clinical investigation to complement the conformity assessment procedure of a class IIa, IIb of III device, you will benefit from our extensive experience in planning, conducting and reporting clinical trials.  This will enable you to achieve your goal -be it initial CE certification or post-marketing surveillance- efficiently and in accordance with applicable laws and regulations.

Our expertise includes:

• Clinical trial design and Clinical Investigation Plan (CIP) development (in accordance with ISO 14155:2011 + Cor. 1:2011)
• Development planning, contact with relevant authorities
• Development and translation of Informed Consent Forms
• Statistical trial design, assessments, analysis and randomization
• Generation of case record form (paper or electronic) and clinical data management
• (Remote)Monitoring plan and clinical monitoring
• Submission to Ethic Committees and Regulatory Agencies
• Set-up and appointment of Data Monitoring Committees (DMC)
• Investigational site selection and qualification
• Serious adverse events, serious adverse device effects and device deficiencies reporting procedure
• Clinical investigation report generation and submission
• CE-marking regulatory support

Medical Writing

Our medical writers are experienced scientists and/or native English speakers with proven expertise in timely and accurate preparation in a wide range of therapeutic areas.

We deliver state-of-the-art reports and study protocols compiled by the Assign Group´s cross-functional teams.
Internally, we work closely with our physicians and statisticians to ensure that the document planning and production delivers consistent data interpretation from study initiation through to study finalization. Our documents are clear and concise, combining language and technical skills, comprising addenda, in-text tables, figures, charts, graphs, bookmarks and hyperlinks of the highest quality.

Appendices to clinical study reports constitute sometimes the largest components and require extensive management and quality control during report creation and assembly.

We ensure that GCP relevant appendices are ICH E3 compliant and complete. We have profound knowledge of all relevant guidelines.

Our deliverables are: Investigator Brochures (IB), Investigational Medicinal Product Dossiers, Clinical Study Protocols for all Phases, Patient Safety Narratives, Clinical Summaries and Overviews, Standard Operating Procedures, Clinical Study Reports, including statistical sections, annexes, hyperlinked and bookmarked according to specific guidelines/requirements

Our processes are based on a qualified wide set of : Standard Operating Procedures, Safety Management Plan, Working procedures, Forms and templates

Fully integrated clinical study reports include: Preparation of result-independent parts of the text based on a review of the clinical study protocol, amendments, case report forms, SAP, investigator‘s brochure, development of in-text tables and figures based on statistical (end-of- text) tables, figures and listings in consultation with the sponsor and external experts as appropriate.

Result-dependent parts of the text (including discussion and conclusions sections) based on statistical analyses, current regulatory guidance, the sponsor’s strategic documents (e.g. target product profile), published literature Integration and cross- referencing of report text, in-text tables and figures, end-of text tables and figures, patient safety narratives, and ready-compiled appendices Integration of any interim analyses as appropriate.

Quality control of the report: consistency, completeness and correctness of all items, cross-references, stylistic elements, terminology, abbreviations and nomenclature hyperlinked and bookmarked, translation of any non-English documentation and as required, preparation of tables of contents and cover pages.

Quality Assurance

Assign is committed to highest quality in all areas of services. We conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products.

Our Quality Management System is shown in: Well structured organization with highly qualified personnel, Standard Operating Procedures (SOPs) describing responsibilities and duties, System and onsite audits, Continuous education program

Pharmacovigilance

Assign provides complete pharmacovigilance services. At the center of our pharmacovigilance process is patient safety and regulatory compliance. Patient safety narratives are written with input provided by the Assign cross-functional teams, who are reviewing all available data and information (e.g., pharmacovigilance database, clinical trial database, CIOMS forms, hospital records, case report forms).

Pharmacovigilance services: Review of Clinical Study Protocol, Set-up of DSMB, DSMB reports, Set-up and maintenance of safety database, SAE handling manuals , Medical review of SAEs and follow-up , Medical assessment of causality and expectedness, Expedited reports (SUSARs) to CAs and ECs/Investigators, SAE tracking and update of SAE documentation , Coding (MedDRA, WHO-DD, ATC), Generation of CIOMS-I forms and line listings, SAE reconciliation, Periodic Safety Reports (PSURs)

Finance Contracting Budgeting

FinAS (Finom Administration System) is a web-based project management and information tool for company-wide team collaboration.

It enables us to manage our client´s projects, contracts, invoicing information online and in real-time .

Based on defined user-access roles, general management, affiliates, project managers and CRAs get different user interfaces with specific information that is needed.

Adminstrational study documents (e.g. protocols, contracts, invoices) are assigned directly to a specific project. It also supports operational planning on a project management level.

Benefits in detail

General management and accounting: Real-time study overview with adjustable tolerance levels for budget deviations, Centralised contact and contract administration with build in customer relationship management (CRM), Invoice tracking – including payment targeting and reminder functionality, Document availability via direct attachment upload at all levels,

Human resources: Clinical research professional history tracking from candidate to retirement, Administration tool for all employee related data and team assignment, including part-time with deviating business days, capacity allocation for multiple team assignments

Project manager: Facilitates team collaboration based on defined skills, Employee workload and operational availability planning at calendar week level, Providing staff with a task schedule for the whole project, Performance control,

Project managers, CRAs: Direct access to relevant study information, Easy to use time reporting on designated work packages,

IT: Access limitation due to User-Access roles, Highly efficient Microsoft SQL Server database
Report generation and distribution via Microsoft reporting services

IMP Handling

ABF Pharmaceutical Services

We have the capacity and experience to supply study medication for any type of clinical trial from single center to multi center trials.

Our services cover: Qualified Person-Services, Primary and secondary packaging, Design and printing of labels, Regulatory advice on label text and translations, Customised secondary packages, Storage management (ambient, refrigerated, -20°C, -80°C), Support with import and export licenses across Europe, Customer focused distribution of the study medication within and outside the EU, Study medication return and destruction, Ambient, frozen, refrigerated storage and distribution

Central Lab

We offer expert, cost effective, flexible solutions. Patient kits, customized Investigator Manual, requisition forms, sampling and shipping instructions as well as labels can be produced according to your requirements.

We have the capacity and store management systems to ensure that all biological storage needs are met – confidently and cost effectively. Here at ABF we have high quality storage facili­ties, equipped with a validated temperature control system. We ship specimens to a third party analytical laboratory as requested.

Central Laboratory Services: Logistics study design, Sourcing of study specific material, Custom kits building and distribution, Biological specimen management and long term storage, Ambient / cooled / frozen / ultra-frozen storage of specimens

Data Management & Biostatistics

At the core of our data management are InterTrial and Oracle® OC/RDC, both fully integrated electronic data capture systems that combine data capture on-site with statistical analysis, pharmacovigilance and reporting.
We are specialized in rapid and efficient programming of the clinical study database, the eCRF and the pharmacovigilance database. Data security, data cleaning, coding and programming follow the highest standards.

Data Management at Assign uses state-of-the-art IT Technology to speed up the data management and analysis process.

Technical standards: Redundant MS Windows Server, MS SQL Server® / Oracle® Database management system, Double-redundant backup strategy, Secured Internet access with Secure Sockets Layer 128 bits encrypted, Secured access for sponsors

Data processing: CRF design is based on extensive experience in many different therapeutic areas, CRF online access for sponsor, CRAs and study management, CRF is the data source for project status reports, Switching pCRF vs. eCRF is possible (per site), Ongoing data entry and data cleaning, Data validation and ongoing query process on demand, Online and offline checks, Study-specific user manuals, Hotline, Coding in MedDRA, WHO Drug Dictionary, ATC, Flexible for CRF design changes, Close integration with analysis software, Standardized export into SAS® (fully labeled)

Our capabilities include: Study design phase I – IV, Sample size calculations, Statistical methods applications, Review of entire protocols and statistical parts, Randomizations, Statistical programming, e.g. descriptive statistics and univariate analysis, linear and nonlinear models, categorical data analysis, Interim analyses, Statistical Analysis Plans, Statistical programming (SAS®), Integrated safety and efficacy analysis Clinical study reports: tables, figure, listings, bookmarked and hyperlinked.

Regulatory Contacts

The understanding and evaluation of the regulatory environment for the various countries, guidelines and products is a complex process where you can benefit from our years of experience and outstanding expertise. We are proud of our distinguished reputation for Regulatory Consulting services and are ready to assist you in creating and following a strategy for success.

Our Regulatory Affairs Department provides comprehensive international expertise to clients at all stages of the drug development process. Assign regulatory teams have broad experience and insight in pre- and post-marketing drug regulations.

With our experience of international regulatory submissions, we are trained in all aspects of the clinical trial submission process, to all regulatory bodies, Central/Local Ethic Committees, Competent Authorities, governmental offices. Your benefit is that our assigned project team is completely involved and in charge from initiation to reporting of results.

Risk Based Monitoring

Efficacious monitoring by experienced professionals is the backbone of data and clinical trial quality. Efficient monitoring brings you fast subject recruitment, compliant site performance and reliable data. Our team ensures the adherence to standard operating procedures and strives to promote positive personal relationships with a high level of trust and confidence with all our clients.

Fundamental basis of our daily work is GCP compliance, adherence to regulatory requirements (including local law) and efficient reporting together with clear communication lines.

Assign offers high quality and delivery based clinical monitoring services to manage a trial in time and within the given budget. Our experienced monitors provide a high level of expertise, efficient services and high end results to the pharmaceutical, bio-pharmaceutical and medical device industries.

Monitoring-Services offered include: Investigator Site Selection, Pre-study qualification visits, EC submissions/approvals, Site Initiation Visits, Organization of Training/Investigator meetings, In-house Monitoring, Clinical Trial Site Management, Clinical Trial On-site Monitoring, Site Close Out Visits, Query Resolution.

Through the assign academy we ensure continuous education for clinical monitors. Regular in-house trainings guarantee knowledge transfer, increase experience and educational levels as per your projects requirements.

Assign’s risk-based monitoring approach is compliance-oriented monitoring taking into account project specifics and individual site performance.

It combines on-site compliance evaluation, remote monitoring techniques and efficient data management tools to direct resources to where they are needed – without compromise in data quality and patient safety.

“Real-time” electronic data capture and data processing allow timely quality assessments to adapt on-site activities to the required extent.

Site visit frequency will no longer be based on a pre-fixed “one-size-fits-all” schedule but be tailored in a flexible and efficient individual compliance related solution.

Project Management

Each of your projects is an investment in the future success of drug development: A competent project manager is key to a successful project performance.

Assign’s project managers have an understanding of your business needs and know how to effectively manage your projects to address these needs. We can ensure that your projects will be completed to the highest quality standards, on time and within budget.

An experienced and dedicated Project Manager leads all phases of your study – providing you with continuous feedback on recruitment, site selection, and how to run each phase – throughout the entire duration of your trial. The project management team proactively monitors study milestones to ensure that your studyis delievered on time and within budget.

In that spirit of partnership, our Project Managers take on the responsibility of being the single point of contact.