BVMA - Bundesverband Medizinischer Auftragsinstitute e.V.

Get to know one other BVMA member: ClinAssess GmbH, Leverkusen BVMA member since 2012   Highlights History: Extensive professional expertise and high-quality services in all areas and phases of clinical trials since 2000. Various indications (oncology, cardiovascular diseases, anti-infectives, central nervous system diseases, etc.). Close contact with opinion leaders and external specialists. Intense cooperation with oncological professional societies, working communities, study groups. Mission: We lead your projects to success. Staff: Highly motivated, competent, interdisciplinary team. Excellent qualifications in medicine, project management, monitoring, data management, biometrics, medical safety, quality management. Competence: Comprehensive know-how in GCP-compliant conduct of clinical trials (Phases I-IV, NIS). Successful processing of various medical study projects (> 400 studies, > 40,000 subjects). 4 BVMA audits and 4 inspections by authorities passed successfully.   Services Takeover of individual components up to realisation of complete study projects. Management of a comprehensive oncology network incl. numerous investigators and trial sites. Project Management: Our project teams are guided by senior project managers with profound knowledge of study planning, development, coordination, administration. Project manager is primary contact for sponsors and trial sites, coordinating all procedures in agreement with you. Medical Writing & Medical Consulting: Our medical experts provide medical advice, evaluation and training in creating study-specific documents. All documents can also be prepared by our medical writers. Monitoring: Our CRAs ensure controlled data collection quality and patient safety at sites. Intense CRA training ensures best possible support (onsite, remote, centralised, adaptive, risk-based monitoring). Data Management: Our data managers care for highest data quality levels (pCRF/eCRF studies). Close interdisciplinary collaboration ensures efficient data cleaning. Benefit from well-coordinated DM procedures, professional database development, DB/data validation, data entry, status reports. Medical Safety Management: Our highly skilled safety experts support your pharmacovigilance/medical device vigilance activities. Benefit from professional AE/SAE/Device Deficiency management, development of safety manuals/vigilance plans, MedDRA coding, safety reporting. Biometrics: Our well-versed biometricians provide statistical services/ consulting during entire study process up to evaluation of results. Services include support in development of study protocols, calculation of power and sample size, generation of randomisation lists, SAPs, exploratory/ confirmatory analyses, sub-group and interim analyses, statistical reports. #BVMA #ClinicalResearch #KlinischeForschung #CRO #Career #WorkWithUs #ClinicalTrials #LifeSciences #ResearchAndDevelopment   www.clinassess.de

🌿 Get to know one more of our members: At KLIFO, we are proud to be part of the German Association of Contract Research Organizations (BVMA). As an integrated drug development consultancy, KLIFO leverages over 25 years of experience in partnering with biotech and pharmaceutical companies to accelerate their development projects. 🔬 Our Expertise: KLIFO provides end-to-end drug development solutions, with specialized services in: - Pre-clinical Development - Pharmacokinetic and Pharmacodynamic Studies (Phase I) - Proof-of-Concept and Dose-Finding Studies (Phase II) - Marketing Authorizations based on Pivotal Studies (Phase III) - Observational Studies and Non-Interventional Studies (Phase IV) - Additional Benefit Assessment as part of the AMNOG Procedure 💡 Key Contribution Areas: - Clinical Development Plans and Execution - Project Management and Leadership - Regulatory Affairs and Compliance - Clinical Trial Supply Management - Data Management & Biostatistics - Medical Writing and Document Management - Clinical Site Feasibility, Selection, and Monitoring - Safety Surveillance and Post-Market Vigilance 🌍 Our Reach: With offices in Denmark, Germany, Sweden, and the Netherlands, and a global footprint covering North America, Europe, and Asia, KLIFO ensures local expertise with centralized operations, delivering personalized solutions and strategic insights. 🌱 Our Mission: KLIFO is dedicated to closing the gaps in development projects, foreseeing and mitigating the complexities associated with developing new medical drugs. We believe in building trust-based relationships and delivering tailor-made solutions by listening to our clients' needs. 👥 Our People: Our greatest asset is our team of over 150 highly qualified professionals whose passion and expertise drive our success. Collaboration, flexibility, and continuous improvement are at the core of our culture. Join us on our mission to shape a sustainable future in medicine and research. Let's accelerate progress together! #BVMA #ClinicalResearch #KlinischeForschung #CRO #DrugDevelopment #Pharmaceuticals #Biotech #KLIFO https://lnkd.in/dJKyQcuh

Psssst …. Das BVMA Symposiums-Programm 2024 ist online. Ein Klick – ein Blick und schnell auf die BVMA Seite (www.bvma.de) gehen und sich einen der begehrten Plätze sichern. Das Programm ist wie gewohnt vielfältig und wie immer auf die im Moment und auch noch im November aktuellen Themen ausgerichtet. Manch ein Teilnehmer bezeichnet unser Symposium schon als Klassentreffen. Unser Get-Together am Vorabend im Veranstaltungshotel ( exklusiv für angemeldete Symposiumsteilnehmende) ist tatsächlich immer ein sehr entspannter Austausch verbunden mit viel Wiedersehensfreu(n)de. Und versprochen, selbst wer das erste Mal dabei ist wird die zwanglose Atmosphäre zu schätzen wissen. Wir freuen uns auf Sie! #bvma #clinicalresearch #klinischeforschung #cro #wefeelresponsible

Today we present one of our oldest member companies: The Science CRO - From Target to Patient Founded in Europe with more than 40 years of experience, Nuvisan is a fully integrated contract research and development, and manufacturing organization (CRO/CDMO) that offers unique, high-quality, and tailored integrated solutions along the drug discovery and development value chain. Keyfacts: 🔍 Focus on Science & Pharma Expertise 💡 Extensive Industry Experience 🤝“Science First“ & Customer Centric Focus 💊 One Partner along R&D Value Chain At our large study clinic in Germany, we conduct early clinical development trials such as first-in-human clinical trials and dose escalation studies with healthy subjects, along with pharmacokinetic studies on healthy subjects, special populations, and patients. NUVISAN's experts also provide high-quality consulting services in addition to practical clinical trial conduct and all related services. Our team can provide advice and support during the transition from preclinical to clinical development, including assistance with calculating the safe starting dose and preparing early clinical trial design. We are familiar with regulatory requirements and can provide support in all aspects of a clinical development program, including regulatory issues and biostatistical planning and evaluation. Nuvisan is pleased to offer the following portfolio of services: • Drug discovery & research - Discovery pharmacology - Discovery bioscience - Screening - Life science chemistry - Translation research - Digital life science - Toxicology – DMPK • Non-clinical studies • Pharmaceutical analysis • Topical formulation development • Chemical development with GMP manufacturing (3-10kg) • Bioanalytical labs • GMP manufacturing (up to 50Kg) • Clinical trial supplies • Phase 1 and 2 clinical studies and beyond Our services can be provided as stand-alone or integrated solutions and can be customized to your project.   We know how to discover, develop, and bring the next generation of medicines to market – all under one roof! To find out more, visit us: www.nuvisan.com   #BVMA #ClinicalResearch #KlinischeForschung #CRO #NUVISAN #Clinicaltrialsupply #integratedsolutions #wefeelresponsible https://lnkd.in/dmej6ecM

Today we are introducing one of our newest member companies: MaganaMed GmbH is a proud new member of the German Association of Medical Contract Research Organizations. As a provider of an eCRF solution we are a bit exotic among all the CROs but we already feel quite at home at the BVMA.   Our philosophy We aim to provide software that people are happy to use because it doesn’t get in their way, fits their workflow and is easy to use. As a small company, we work closely with our customers – they share their needs, ideas and challenges with us so we can further improve our software to make their work easier.   Our service MaganaMed provides a web-based eCRF software for clinical data collection with various features such as EDC, ePRO, eCOA, eDiary, eSurveys, Randomization, Biosample Management, and more. If needed, we offer custom solutions to suit your needs.   Our customers We mainly support small to mid-sized CROs, medical device and diagnostics manufacturers, academic institutions as well as small to mid-sized biotech and pharma companies in conducting clinical studies for regulatory approval, clinical evaluations, post market surveillance and clinical follow-ups and research. #BVMA #ClinicalResearch #KlinischeForschung #CRO #EDC #eCRF #wefeelresponsible https://lnkd.in/d4N2gHh2

In diesem Jahr veranstaltet der #BVMA sein 32.Symposium und wir hoffen, dass Sie sich spätestens jetzt den Termin fest in Ihren Kalender eintragen. Das Programm ist in der finalen Abstimmung und wir freuen uns auf spannende und begeisternde Vorträge zum diesjährigen Titel: Studienstandort Deutschland -  Neue Impulse für die klinische Forschung Nach der erfolgreichen Premiere im letzten Jahr, treffen wir uns auch heuer wieder mitten in München: am 22. November 2024 im Holiday Inn Munich-City Centre Derzeit herrscht eine enorme Dynamik in der klinischen Forschung. Mit dem bevorstehenden Inkrafttreten des Medizinforschungsgesetzes in diesem Jahr sollen zumindest einige der bestehenden Defizite in Deutschland behoben werden. Dies erfordert umfassende Diskussionen, um die besten Lösungen für die Umsetzung zu finden. Angesichts der rasanten technischen Entwicklungen müssen regulatorische Rahmenbedingungen, Innovationen, KI-Anwendungen und praktische Lösungen ständig neu ausbalanciert werden. Das bevorstehende Symposium wird alle aktuellen Themen aufgreifen und zusätzlich in einer Round-Table-Diskussion den Studienstandort Deutschland sowie zukünftige Anforderungen erörtern. Freuen Sie sich auf ein abwechslungsreiches Programm und anregende Diskussionen, die Sie nicht verpassen dürfen. Natürlich findet auch in diesem Jahr unser traditionelles „Get-together“ am Vorabend (21.11.) statt. Wir treffen uns hier wie gewohnt in entspannter Atmosphäre im Veranstaltungshotel. Das finale Programm finden Sie Ende Juni auf unserer Webseite. Wie immer ist es eine reine Präsenz-Veranstaltung, denn nichts geht über ein persönliches Treffen. So ist es möglich Kontakte zu vertiefen, neue Menschen kennenzulernen und sich mit hochkarätigen Referenten zu aktuellen Themen auszutauschen. Wir freuen uns auf den 22. November und hoffen, Sie bereits am Vorabend in München begrüßen zu dürfen. Anmeldungen sind übrigens jetzt schon möglich. #bvma #cro #clinicalresearch #klinischeforschung #klinischestudien #studienstandortdeutschland #wefeelresponsible

#EucrofWebinar A truly hot topic will be covered in our next webinar on “Transition of #clinicaltrials from CTD to the legal framework of the CTR”. As the deadline for transition from the EU Directive 2001/20/EC (CTD) to the EU Regulation 536/2014 (CTR) is fast approaching, all sponsors are requested to submit their transition trials on time and as soon as possible. Dr. Dagmar Chase GCP Consultant and Trainer at Clinrex and Dr. Iris Romero Matuschek, Senior Manager, Regulatory Affairs, at ICON will present the regulatory background for the transition of clinical trials from one legal framework into the other along with new transparency rules.  👉When? Thursday, June 4 | 3 - 4.30 pm CEST Reserve your spot today by following this link: https://lnkd.in/eMzdT4Dw #ctr #ctd #clinicalresearch #ema #cro #ctis

In einem halben Jahr ist es soweit! Wir freuen uns darauf, beim 32. BVMA Symposium dabei zu sein! 🙌 BVMA - Bundesverband Medizinischer Auftragsinstitute e.V. - In half a year the time has come! We are looking forward to being part of the 32nd BVMA Symposium! 🙌 #TRIGA-S #IVD #BVMA

We are happy to introduce another BVMA member: History and Mission   Eurofins bioskin is a leading full-service CRO with unique understanding and capabilities for dermatological clinical trials. Recognized by global companies as a valuable partner in trials for drugs, medical devices, food supplements and aesthetics since 1992, Eurofins bioskin provides early phase safety and Proof-of-Concept studies and global Phase II-IV trials.   Highlights   Eurofins bioskin has performed 600+ clinical trials in 20+ dermatological indications including 30,000+ patients and healthy volunteers with 140+ sites in 15 countries. For global early and late phase studies we partner with selected, reliable vendors throughout Europe, US, Latin America, Central Eastern Europe and South Africa. We manage clinical trials in all dermatological indications with a special expertise in psoriasis, alopecia, aesthetics and wound healing. Our in-house dermatologists consult on study design and interpretation of results. We have been awarded the 14155:2020 certificate, a globally recognized certification of the ISO 14155 standard for the design, conduct, recording, and reporting of medical device clinical investigations in human subjects.   Services   Phase I and Proof-of-Concept studies at our Research Center ·        Risk mitigation by early recognition of cutaneous safety issues ·        Unique innovative designs to evaluate efficacy in early clinical development ·        Integration of biophysical measurement methods   Phase II – IV Multinational Trials ·        Conduct of multinational dermatology trials across Europe ·        Selected SMO/CRO partners for international studies ·        Global project leaders and central coordination   💡 Clinical Trial Management ·        Leading of international teams for late phase as well as for early phase studies ·        Submission of clinical trials according to EU Regulations (CTR, MDR) and/or national regulations/laws in- and outside the EU ·        Electronic Trial Master File (eTMF)   📈 Medical Monitoring ·        Review of clinical trial protocol and report with dermatological expertise ·        Continuous medical oversight ensuring subject safety and trial integrity   🔎 Monitoring ·        In-house CRAs and team of freelance CRAs ·        Risk based monitoring/remote monitoring   📊 Data Operations ·        Design and development of eCRFs and clinical database ·        Electronic data transfer in SDTM format (CDISC compliant) ·        Statistical consultation on study design ·        ADaM datasets (CDISC compliant)   💻 Medical Writing ·        Clinical trial protocols, clinical investigation plans and reports, informed consents ·        Scientific publications ·        Lay language summaries   #BVMA #ClinicalResearch #KlinischeForschung #CRO #Eurofinsbioskin #Dermatology #FIH #POC #ResearchCenter   https://lnkd.in/e-tHZyEj

Das 32. BVMA Symposium findet heuer am 22. November 2024 in München statt. Wir freuen uns, Ihnen bereits jetzt schon den Titel präsentieren zu können: Studienstandort Deutschland - Neue Impulse für die klinische Forschung Das Programm ist fast finalisiert und bald können auch Sie einen Blick darauf werfen. Seien Sie gespannt! Wir können Ihnen versichern, dass wir wieder spannende Referenten mit interessanten Themengebieten gewinnen konnten. Auch eine Podiumsdiskussion ist geplant: Wie steht es um den Studienstandort Deutschland? Wir freuen uns auf die Veranstaltung und natürlich auf Sie, denn nur durch Ihr Kommen wird dieser Tag eine runde Sache. Und wir hoffen, dass Sie viele neue Impulse mit nach Hause nehmen. Vielleicht sogar schon vom Vorabend. Da findet wieder das allseits beliebte Get-Together statt - mit Snacks und Drinks in lockerer Atmosphäre. Anmeldungen sind ab sofort möglich. Wer ist die Nummer eins? #bvma #clinicalresearch #klinischeforschung #klinische Studien #cro #wefeelresponsible