Co-design | Regulatory
Clinical research, and its inherent complexity and regulatory context, requires strict compliance with procedures to ensure the quality of trials. Alsinova surrounds you with experience and know-how to secure the end-to-end success of your clinical projects. Thanks to an approach based on expertise, agility, data and innovation, Alsinova offers all the services required for efficient management of your trials, without compromising on quality or on the schedule, and always within the budget.
We apply advanced collaborative design engineering to craft minimally disruptive studies, integrating patient insights and carefully selecting data sources.
Our approach ensures efficiency, relevance, and innovation while respecting all standards and guidelines of the scientific community.
Alsinova co-designs with each sponsor the optimal study that can start as quickly as possible, collect the most data with the least effort, and ultimately publish as soon as possible.
With expertise in GDPR and cybersecurity, we help choose the best regulatory framework (RIPH 2 vs RIPH 3; MR001-3 vs MR004 vs CNIL authorization). We also offer a transparent assessment of mobilizable data sources (investigator sites, patients, connected objects, SNDS, etc.) to meet your study objectives, which can be formalized if needed in a position paper.
Our team is equipped to manage the entire preparation phase, from pre-synopsis to regulatory instructions (CPP, ANSM, CNIL, Health-Data-Hub). We bring proven experience in managing scientific advice and involving patient associations from the protocol writing stage to optimize its acceptability (CPP) and operational execution.
Medical Writing
Alsinova provides all medical writing services, from writing (or optimizing) protocols, developing CRFs and e-PROs, to writing abstracts and scientific communications.
We have expertise in protocol writing, where data flows must be carefully described to optimize regulatory steps (CPP and CNIL).
We are committed to the user experience, designing e-CRFs and e-PROs with a mixed team of medical writers and digital experts, ensuring they are easy to complete and generate the most analyzable data as early as possible.
We also have the ability to write abstracts in English or French, with a high acceptance rate in international conferences, and to produce subsequent scientific communications (posters, e-posters) according to your graphic templates.
We are experienced in producing documents that highlight (pre)results for use by sponsor teams or for the management of scientific committees.
Additionally, we are proficient in producing end-of-study medical reports, and if needed, we can leverage our network of partners for specific situations (e.g., medical device registration dossiers, etc.).
Clinical Operations
Through its in-depth experience of clinical project management, Alsinova anticipates risks and proposes solutions to meet your challenges. Our monitoring team operates across Europe and North America.
Monitoring in other regions is outsourced to reliable, qualified partners.
Site Management
Alsinova handles all operations related to investigator sites, from selection to contractualization and payment tracking.
(As per the sponsor’s choice) We have the ability to identify and select sites using available open-data sources (mass mailing, direct mail, etc.).
We bring experience in contract negotiation under tight deadlines and working with Clinical Research Departments. Upon request, contracts can be validated by our partner, the law firm Beslay.
We offer in-person or fully digital site initiation visits, with personalized follow-up (see monitoring) to obtain regulatory documents (e.g., task delegation, etc.).
We ensure seamless site engagement from selection to closing with a dedicated single point of contact (Site Manager), fostering stronger relationships and adherence.
Backed by a CRM-like system, every interaction is securely tracked, ensuring continuity even in the absence of the primary contact.
Our platform provides automatic tracking of site activities, ensuring simplified and more reliable invoicing. We also have the capability to integrate specific sponsor SOPs (pre-validation of Pass Through Costs).
We manage payments through a separate bank account and have experience with transparency declarations in compliance with regulatory requirements.
Monitoring
Alsinova ensures the smooth running of the study at each site, in terms of enrollment pace, data density, and available resources.
Alsinova’s Clinical Research Associates (CRAs) are experienced professionals equipped with digital tools, enabling them to work more efficiently with analytics tailored to each study and presented through daily objectives.
A close relationship: Each CRA is responsible for dedicated sites, ensuring a close relationship, supported by a system for managing communications (email, phone system, tasks, milestones) to guarantee total resilience.
Risk-based site monitoring driven by data, using a fully automated information system that allows continuous analysis to identify gaps in data density and potential risk practices.
Alsinova has the capacity to allocate resources for data entry assistance to investigator sites when there is an identified need, such as understaffing or frozen data.
Alsinova ensures the quality of data entered at sites and compliance with the protocol.
Several approaches are offered depending on the study’s quality requirements and the sponsor’s preferences, in accordance with the study’s monitoring plan:
Systematic on-site monitoring or RBM (Risk-Based Monitoring) or random monitoring
On-site quality control
Remote monitoring
These activities can be carried out in partnership with Optimarc.
Data & analytics
Alsinova offers a comprehensive range of data-analytics services that cover the entire data management & analytics lifecycle, from pre-clinical and non-clinical research, to clinical trials and real-world evidence studies. Our solutions ensure the integrity, quality, and insightful analysis of complex datasets at every stage. From managing pre-clinical and non-clinical data, through optimizing data collection and statistical analysis for clinical trials, to providing deep insights into real-world data, we enable informed decision-making and accelerate the understanding of treatment effectiveness and safety in real-world settings.
Alsinova offers advanced data-analytics solutions for managing clinical trials and real world studies. From data collection to statistical analysis, we optimize every step to ensure reliable and robust conclusions for your clinical studies. Our tools provide enhanced monitoring, strengthened quality control, and in-depth result analysis to accelerate decision-making
We offer A high level of responsiveness in analysis, thanks to extensive automation of SAS and R programming and a secure data chain from baseline freeze to analysis.
We provide methodological support in advance to help make the best design choices (such as experience with adaptive designs or indirect comparisons).
We offer flexibility for database formats and analyses based on the study’s requirements, including the CDISC format (CDASH – SDTM – ADaM).
SNDS
Alsinova holds the accreditations and experience to manage all your study projects on the SNDS: from rapid EGB analysis to hybrid cohort matching.
- Study Office since November 2017 (RERC171027)
- Member of AFCROs, Real World Data group
- Member of REDSIAM
We offer exploration via EGB (Echantillon Généraliste de Bénéficiaires) to quickly estimate trends or build artifacts. Alsinova is the first study office in France to have successfully completed the simplified access procedure to EGB (access process in less than 15 days).
We provide complete analysis via SNDS to obtain robust information from a world-class database.
We also offer the ability to link SNDS to your prospective studies (hybrid e-cohort) through probabilistic matching or NIR, obtaining complementary data (treatment history, hospitalizations, etc.), tracking the outcomes of lost-to-follow-up patients, and more.
Vigilance & Regulatory Affairs
Alsinova provides comprehensive regulatory affairs support across a wide range of products, including pharmaceuticals, medical devices (MD), in vitro diagnostic devices (IVD), cosmetics, and food supplements, both in pre-market and post-market phases. Our expertise covers the entire product lifecycle, from initial submission to managing renewals, variations (quality, safety, administrative), extensions, and withdrawals of marketing authorizations (MA), all while ensuring compliance with local and international regulatory requirements (EU, US, and other regions).
The regulatory environment is continuously evolving, with frequent updates to requirements and procedures. To address these challenges, we have developed innovative technology solutions powered by artificial intelligence enabling time savings, improved efficiency, and enhanced compliance. These tools help automate complex regulatory tasks, improve data management, and better anticipate regulatory changes, simplifying the navigation through this ever-changing landscape.
Pharmaceuticals
We provide full support for pre- and post-MA activities, including submission of authorization dossiers, managing variations, renewals, as well as ensuring CMC (chemistry, manufacturing, and controls) compliance, and supporting clinical and non-clinical studies.
Medical Devices
We assist manufacturers in complying with European (MDR) and international standards by offering regulatory strategy, design control, technical documentation, and lifecycle compliance management, from product design through commercialization.
In Vitro Diagnostic Devices
We provide compliance solutions for IVDs, ensuring a smooth transition to the IVDR requirements, including managing technical dossiers, CE marking requirements, and post-market surveillance.
Cosmetics
We help companies develop, authorize, and bring their cosmetic products into compliance globally, ensuring product safety and efficacy while adhering to local regulations (EU, FDA, etc.).
Food Supplements
We provide a comprehensive regulatory strategy for food supplements, ensuring compliance with health claim regulations, ingredient safety, and adherence to local and international regulations.
Through our innovative AI-powered solution RegIntel, we enable our clients to reduce processing times, increase efficiency, and maintain consistent compliance with evolving standards. We offer a personalized approach, anticipating the specific requirements of each market and guiding you through all stages, from development to commercialization, to ensure the success and regulatory compliance of your products globally.
Our global vigilance team, with experts located in multiple countries, specializes in clinical safety and vigilance across a range of product categories, including pharmaceuticals (Pharmacovigilance), medical devices, food supplements, and cosmetics. We are equipped to support you at every stage of your product’s lifecycle, from clinical development, through the submission and marketing authorization phases, and all the way to post-marketing surveillance. Our vigilance services extend to maintaining product safety and regulatory compliance long after market approval.
Our team is adaptable and flexible, tailoring our services to meet the specific needs of each client and has extensive experience working within various client environments, adhering to client-specific processes.
Key Services (Not exhaustive) :
Whether you’re in the early stages of clinical trials or managing a marketed product, our global vigilance team is committed to ensuring the safety and compliance of your products while adapting to the unique needs of your business
Innovative Solution for Adverse Event Report Processing and Compliance Tracking
In addition to our core vigilance services, we have developed a cutting-edge solution RegIntel for Compliance Tracking. This tool includes an intelligent chatbot that is designed to process adverse event report documents efficiently. The chatbot compares these documents against general regulatory guidelines and provides users with the appropriate reporting information based on current safety standards. This innovative solution not only enhances the efficiency of adverse event reporting but also ensures compliance with the latest global regulations.