Oncology.

ASSIGN has successfully supported more than 190 oncology studies, covering over 35 indications within this therapeutic area. This makes oncology and oncologic studies our core expertise and focus. Our experience can add value to your study by providing access to key investigators, experienced study centers, networks of specialized labs (CTC/DTC/PBMC), insightful study design and much more.

Cancer Immunotherapy.

Immunotherapy represents a novel approach to cancer treatment. From the cervical cancer vaccine to the first therapy ever proven to extend the lives of patients with metastatic melanoma, immunology has already led to major breakthroughs in a number of cancers. ASSIGN has designed and conducted several clinical immunotherapy trials in oncologic indications such as prostate cancer, ovarian cancer and colorectal carcinoma, to name a few. Our non-oncologic immunotherapy trial experience includes indications such as Lupus Erythematosus, Rheumatoid Arthritis and Crohn’s disease.

Vaccines.

At ASSIGN, we understand the importance of timing, experience and flexibility for the successful execution of a vaccine study, which is why all our vaccine studies have been completed on time and on schedule. Our track record spans both preventive and therapeutic vaccines, subunit and conjugates across all phases I-IV in more than 15 countries, 190 study centers and 2500 patients.

Personalized Medicine.

ASSIGN has been at the forefront of the advance into personalized medicine, supporting several highly personalized dendritic cell studies, as well as protein fragment-based therapeutic cancer vaccine projects. Through this, we have gained tremendous insight and knowledge into the conduct, therapeutic necessities, recruitment issues and logistics of personalized medicine studies.

Trends in Clincal trials - Part I - CTC

Greater than 90% of deaths in cancer patients can be attributed to metastasis. Circulating tumor cells (CTCs), cells that are shed by the primary tumor into circulation, initiate this transition into metastasis. A growing body of evidence points to CTCs as a promising biomarker to non-invasively monitor tumor progression and treatment efficacy. CTC isolation and characterization can however be a challenging process, and requires specialized expertise to be carried out effectively.

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Challenges

Our flexibility as “the right size” CRO puts us into a position to adapt to the ever increasing complexity of clinical trials. Whether they are “difficult to recruit” trials in orphan indications, multi-arm trials with sophisticated IMP setup or trials with heavy recruitment competition, or trials in unconscious patients, we can do the necessary and deliver robust and reliable results. If you are looking for “adaptive clinical trial designs”, our experienced biostatisticians will find tailor made solutions together with you.

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Trends in Clincal trials - Part II - CPD

The traditional approach of separating clinical development into distinct phases is currently being reviewed. Continuous Phase Design provides an alternative path for clinical development by allowing seamless transition from Phase II to III. Thoughtful study design and continuous assessment can reduce product development time from 15 to 7 years (on average), reducing sample size and expense.

Assign has the knowledge and expertise to maximize efficiency in clinical trials, to help you save valuable time and resources.

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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
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Medical Writing

Our medical writers are experienced scientists and/or native English speakers with proven expertise in timely and accurate preparation of documentation across 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 sometimes constitute the largest component of the report 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 and broad set of: Standard Operating Procedures, Safety Management Plans, 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.

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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 demonstrated by: A well structured organization with highly qualified personnel, Standard Operating Procedures (SOPs) describing responsibilities and duties, System and onsite audits and a continuous education program.

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Pharmacovigilance

Assign provides the complete panel of pharmacovigilance services. At the core of our pharmacovigilance processes are patient safety and regulatory compliance. Patient safety narratives are written with input provided by the Assign cross-functional teams, who review 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)

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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 and invoicing information online and in real-time.

Based on defined user-access roles, general management, affiliates, project managers and CRAs each have different user interfaces which display the relevant information.

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

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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, Customized 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

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Central Lab

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

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

Central Laboratory Services: Logistics study design, Sourcing of study-specific material, custom kit building and distribution, biological specimen management and long term storage, be it ambient / cooled / frozen / ultra-frozen storage of specimens

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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 adhere to the highest standards.

Data Management at Assign uses state-of-the-art IT systems 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.

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Regulatory Management

Understanding and evaluating the regulatory environment of various countries, guidelines and products is a complex process. By partnering with us, you can tap into our years of experience and in-depth expertise. We are proud of our distinguished reputation for Regulatory Consulting services and are ready to assist you in creating and implementing 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 up to reporting of the study results.

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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.

The 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’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.

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 training guarantees knowledge transfer while, increasing experience and educational levels as required for your project,

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, biotechnology and medical device industries.

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Project Management

Each of your projects is an investment in the future success of drug development: A competent project manager is key to 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 study is delivered on time and within budget.

Our Project Managers take on the responsibility of being the single point of contact for your project, making communication simple and effective.

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