Advanced Research Projects Agency for Health (ARPA-H) launched its Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic (ET), aiming to: 🔸 Advance new quality assurance technologies at Academic Medical Centers 🔸Accelerate the collection of evidence necessary to establish reimbursement pathways to treat rare diseases 🔗 https://hubs.li/Q02NgC890 #Research #Innovation #raredisease
About us
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant.
- Website
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http://www.veristat.com
External link for Veristat
- Industry
- Research Services
- Company size
- 501-1,000 employees
- Headquarters
- Southborough, Massachusetts
- Type
- Privately Held
- Specialties
- Strategic Consulting, Safety Management, Data Management, Biostatistics, Statistical Programming, Project Management, Medical Writing, Regulatory Submissions, Adaptive Clinical Trial Design, Site Monitoring, Regulatory Consulting, Clinical Trial Patient Recruitment, Clinical Trial Data Standardization, Clinicl Trial Design, Clinical Trial Management, US Regulatory Agent, Pharmacovigilance, Marketing Applications Support, IND Support, Regulatory Publishing, Biologic, Gene Therapy, Full-service CRO, and Oncology Clinical Trials
Locations
Employees at Veristat
Updates
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❗Important Update on Clinical Trials in Switzerland New amendments to the Swiss legislation on clinical trials and human research take effect on 1 November 2024. Changes impact the governing of clinical trials, medical devices, and other human research. Veristat can ensure your research complies with the updated standards 👇https://hubs.li/Q02NgBSK0 #ClinicalTrials #Compliance
Upcoming Changes to Clinical Trials Legislation
veristat.com
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The FDA published guidance on the electronic submission template for medical device De Novo requests. The guidance: ▶ Describes overall standards to prepare the electronic submission of De Novo requests ▶ Does not specify the eSTAR user-interface and content ▶ Informs manufacturers that eSTAR will be the only template from October 2025 onwards https://hubs.li/Q02NgxPv0 #regulatoryaffairs #medtech #MedicalDevice
FDA Guidance on Medical Devices De Novo Requests
fda.gov
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🎉 We’re thrilled to share that we’ve reached several key milestones in the last two weeks of August. Every win is a result of our team’s relentless focus on delivering top-tier clinical research services and making a difference in patients’ lives. Here’s to more groundbreaking achievements as we continue our journey together! 👉 Want to learn more about our work and how we’re advancing clinical research? Visit https://hubs.li/Q02N8TVs0 for more information! #VeristatWins #ClinicalResearch #TeamExcellence #NDA #ClinicalTrials
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Maximize efficiency and results with Veristat! ⏩ Our medical writers can accelerate summarizing data into concise, accurate reports, in compliant formats across the lifecycle of your therapy’s development. Get access to: 🔷 Rapid turnaround 🔷 Flexibility 🔷 Efficient processes How can we help solve your medical writing challenges? 👇 https://hubs.li/Q02MtQKf0 #MedicalWriting #ClinicalTrials #Biotech
Medical Writing for Clinical Trial Documentation & Regulatory Submissions
info.veristat.com
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The FDA issued final guidance to support sponsors in their meeting requests with the agency. The guidance applies to products subject to product-specific guidance (PSG) and covers: 👉 The three types of PSG meetings (i.e. teleconferences, pre-submission, post-submission) 👉 Elimination of the 60-day deadline to request a PSG teleconference after publication 👉 What sponsors can expect from FDA during a teleconference 👉 PSG post-submission requests https://hubs.li/Q02MtKhY0 Ensure your FDA interactions are a success with support from Veristat. #pharmaceutical #healthcare #medicalaffairs
FDA Final Guidance on Product-Specific Guidance Meetings
federalregister.gov
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Developing a novel therapy for a rare/ultra-rare disease? 35% of the work we do supports rare and ultra-rare clinical research. Our scientific-minded experts are ready to accelerate your rare disease clinical trial to its next milestone > https://hubs.li/Q02MtLgJ0 #RareDisease #Biotech #ClinicalTrials
Rare Disease Clinical Trial and Regulatory Submissions | Veristat
veristat.com
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Health Canada | Santé Canada initiated a consultation pertaining to draft guidance for expanded access to clinical trials for patients who do not qualify for other trials or are not able to participate in one. The guidance: ➡ Describes the regulatory requirements ➡ Details procedures for obtaining authorization ➡ Provides information for participants and healthcare providers regarding access to novel therapies via an expanded access trial 📝 Public comment is open until 31 Oct 2024 > https://hubs.li/Q02MtM2f0 Take a patient-centric approach to your communication with Veristat. #clinicalresearch #clinicaltrials #raredisease
Health Canada Consultation on Expanded Access Clinical Trials
canada.ca
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Nothing is more important than collecting clean clinical trial data, especially if you plan to use that data for your marketing application. Learn the 3 questions you should be asking today to arrive at the ideal database design for your trial 👇 https://hubs.li/Q02Mtz8G0 #DatabaseDesign #ClinicalTrialData #MarketingApplications
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The European Commission opened public consultation on common specifications for in vitro diagnostics (IVDs) that focuses on: 🔸 Certain class D IVDs for the detection of e.g. hepatitis E virus and four types of arboviruses 🔸 Addressing associated public health risks and patient safety concerns 🔸 Keeping manufacturer compliance voluntary until the date of application of the Implementing Regulation Feedback can be submitted until 16 Sept 24 > https://hubs.li/Q02MGvBz0 #MedicalDevices #invitrodiagnostics
EU Consultation on Common Specification For IVDs