Two Labs ’s Post

It's fascinating to witness the pharmaceutical industry's shift towards more complex therapies and the crucial role that early integration of medical affairs plays in this transformation. By embedding robust data analytics and regulatory expertise right from the outset, we're not only enhancing compliance but also refining clinical trials for better patient recruitment and real-world applicability. This proactive approach is vital for streamlining drug development and optimizing outcomes, marking a significant evolution in bringing therapies to those needing them.

In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset. Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi

Best practices for Sponsors and CROs to master clinical site engagement. 🏥 Learn how to establish strong relationships with investigators, foster effective communication channels, and provide ongoing support and training. Understand the importance of leveraging technology solutions. https://hubs.li/Q02wP1L60 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #SiteManagement #Sponsors #CROs #Salesforce

Decentralized clinical trials are taking the healthcare industry by storm, but pharmaceutical companies should bear in mind that this model may not always be the most effective.     How do you determine which strategies are optimal for ensuring research is both insightful and manageable for participants?    Talk to patients!      As Executive Director of Decentralized Clinical Trials at Worldwide Clinical Trials, Scott Palmese says, “Understand when patients will welcome decentralized tactics, and when they will not. If you don’t know the community, perhaps you should not be blanketing tactics that may not make sense and could drive patients away.”    Learn more about the role of decentralized trials below: https://lnkd.in/eZMHXbiK #patientvoices #patientcentric #clinicaltrials 

🔑 Tips to Strengthen Clinical Trials by Improving the Patient Experience by pharmaphorum. 💡 Clinical trials designed without patient input risk missing the mark. A patient-centric approach not only improves trust in the pharmaceutical industry but also boosts enrolment, engagement and retention—accelerating access to better medicines. Here’s how sponsors can economically integrate patient experiences into trial designs: - Simplify: Streamline processes and use plain, accessible language to connect with participants. - Offer Options: Design flexible protocols that accommodate diverse patient needs, like virtual visits or support for transportation. Tools to Use: Leverage resources like TransCelerate’s Clinical Trial Registration Tool for patient-friendly descriptions and the Study Participant Feedback Questionnaire (SPFQ) to gather real-time feedback during the trial. 🌟 Options that fit patients’ lives lead to better participation and stronger research outcomes. Read more about it: https://lnkd.in/dc8-rXpx #PatientCentricity #ClinicalTrials #HealthcareInnovation #PatientExperience

Best practices for Sponsors and CROs to master clinical site engagement. 🏥 Learn how to establish strong relationships with investigators, foster effective communication channels, and provide ongoing support and training. Understand the importance of leveraging technology solutions. https://hubs.li/Q02wP17F0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #SiteManagement #Sponsors #CROs #Salesforce

FDA Draft Guidance on Diversity Action Plans: Implications for Pharmaceutical Marketers The FDA has just issued the long-awaited, crucial draft guidance aimed at enhancing diversity in clinical trials through the implementation of Diversity Action Plans (DAPs). This directive is a significant move to ensure clinical trial participants reflect the diverse populations that will benefit from approved clinical products & has been one of the core topics addressed by Race in STEM and our #ClinicalTrialsOBQ 🔥 LinkedIn Audio Group during the past year. LINK: https://lnkd.in/gqFtZX4y “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step...to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.” > Key Requirements and Changes Mandatory Diversity Action Plans: Sponsors are required to submit DAPs detailing enrollment goals disaggregated by race, ethnicity, sex, & age for Phase III/pivotal studies. This is an opportunity to help define how an innovator's cultural launch messaging will align with the clinical patient segmentation. Regulatory Standard: FDORA (Food and Drug Omnibus Reform Act of 2022) mandates these goals be established before clinical trial initiation, aligning with the existing standard for inclusive clinical development programs. The regulatory standard makes early marketing engagement in the clinical plan a prerequisite. > Why This Matters Clinical Relevance: Diversity in clinical trials is crucial because diverse clinical trial participation ensures that the data reflects the real-world diversity of patients who will benefit from the medical products once approved - a requirement to prove safety & efficacy. Health Impact: Improved diversity in clinical trial data leads to better health outcomes by providing insights that are applicable across different demographic groups, thus enhancing the safety & effectiveness of new therapies. Patient-Centered: The guidance encourages patient advocate engagement & directs innovator companies to champion a JEDI (Justice, Equity, Diversity, Inclusion) approach to therapy development. > Opportunity to Engage Stakeholders are encouraged to provide feedback on the draft guidance via Regulations.gov within 90 days of publication. Comments are welcome & can be submitted electronically at [Regulations.gov](https://lnkd.in/gKA-pzuY]. This is a unique opportunity to contribute to a crucial initiative that aims to make clinical research more inclusive & equitable. #JEDI #DEI #representation #patientrecruitment #clinicaldevelopment biomedwoRx: Life Sciences Consulting

🚀 FDA LDT Final Rule Free Resource 🚀 👉 Clinical Validation of LDTs is required by FDA. 👉 Validation studies for IVDs MAY include clinical investigations as noted in FDA's webinar last week. FDA is planning a webinar on this topic in 2025. ❓ Would you like to get a head start on your clinical validity gap analysis❓ 👀 this FDA guidance "Design Considerations for Pivotal Clinical Investigations for Medical Devices Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff " https://lnkd.in/eHp3eE6Y This is a really helpful guidance with lots of information-some highlights: 👉A pre-submission is valuable to align with FDA on clinical validation studies that are both practical and adequate! 👉 If a clinical investigation study is conducted in the US it must comply with the applicable regulations found in 21 CFR Part 56 (IRBs), Part 50 (informed consent) & Part 812 (investigation device exemption (IDE). 👉Often a diagnostic clinical performance study where clinical performance is characterized by measure(s) that quantify how closely the diagnostic device output is associated with a clinical reference standard that is used to assess patients for the target condition. 👉Establishes clinical performance & supports a favorable risk/benefit analysis in the target population (intended use!). 👉A clinical reference standard, for regulatory purposes, is the best available method for establishing a subject’s true status with respect to a target condition (e.g., the pathological result of a biopsy to determine the presence of breast cancer). It can be a single method or a combination of methods and techniques, including clinical follow-up, but it should not consider the investigational device output! 👉The “best available method” is established by evidence from current practice within the medical, laboratory, and regulatory communities.  👉Sometimes, a clinical reference standard does not exist/is not available, or cannot be used in a clinical study due to its invasive nature. In such cases a comparator that is not a clinical reference standard (a non-reference standard) may be pre-specified and used, and these results are compared to the investigational device output. This is called an agreement study & the goal is to demonstrate non-inferiority. 👉The clinical validation protocol should, include the following:  ✍ scientific rationale for the study  ✍ definition of the subject populations to be evaluated (including the inclusion/exclusion criteria) ✍ identification of the proposed intended use for the device ✍ listing of the study endpoints  ✍ statement of the procedures (treatments and tests) that will be applied to study subjects ✍ a summary of the methods of analysis and an evaluation of the data derived from the study, including any appropriate statistical methods utilized 👉Glossary at the end with clinical validity-related terminology.

In order to efficiently manage #ClinicalTrials, various technologies and systems have been developed. Two such technologies are IWRS and #RTSM. Read on as we'll delve into the key differences between #IWRS and RTSM and explore their respective roles in clinical research. Read More: https://lnkd.in/d4rhXQwQ #Octalsoft #IRT #IVRS #eClinical #Clinicaltrial #Clinicalresearch #ClinicalStudy #EclinicalSoftware #PharmaceuticalIndustry #PharmaTech #Pharma #Pharmaceutical #Healthcare #HealthcareIndustry #HealthcareSector #HealthcareInnovation #Blog #Blogs

ABAYE Management Limited was founded in 2014 as a consultancy firm in clinical trials & offers a wide range of services to pharmaceutical, biotech, and medical device companies. 1. Clinical Trial Design & Planning: * Protocol Development: Develop comprehensive and robust clinical trial protocols. * Study Design Optimization: Advise on innovative trial designs, including adaptive trials, basket trials, and pragmatic trials. * Feasibility Assessments: Conduct thorough feasibility assessments to evaluate the viability of a clinical trial, considering factors such as patient availability, site capabilities, and regulatory landscape. 2. Clinical Trial Execution: * Project Mgmt: Provide expert project management services to oversee all aspects of trial execution, from site selection and patient recruitment to data analysis. * Vendor Selection & Mgmt: Assist in identifying and selecting qualified vendors for various trial-related services, e.g. central laboratories, imaging providers, & patient recruitment companies. * Monitoring and Oversight: Conduct regular monitoring visits to trial sites to ensure compliance with protocols, GCP guidelines, and regulatory requirements. 3. Regulatory Affairs and Compliance: * Regulatory Strategy: Develop and implement regulatory strategies for clinical trials, including interactions with regulatory authorities and preparation of submissions. * Ethical Considerations: Advise on ethical considerations related to clinical trials, including informed consent, patient privacy, and data protection. * Quality Assurance: Implement quality assurance measures to ensure data integrity, compliance with GCP guidelines, and adherence to all applicable regulations. 4. Data Management and Analysis: * Data Collection and Management: Develop and implement data management plans to ensure accurate and efficient data collection, processing, and storage. * Statistical Analysis: Provide statistical expertise for trial design, sample size calculation, data analysis, and interpretation of results. * Medical Writing: Prepare clinical study reports, manuscripts for publication, and other regulatory documents. 5. Patient Recruitment and Engagement: * Recruitment Strategies: Develop and implement effective patient recruitment strategies, leveraging digital technologies, social media, and community outreach programs. * Patient-Centric Approaches: Advise on incorporating patient-centric approaches into trial design and conduct, i.e remote monitoring, telehealth, & patient-reported outcomes. 6. Training & Education: * GCP Training: Provide GCP training to clinical trial staff and investigators to ensure compliance with ethical & regulatory standards. * Therapeutic Area Expertise: Offer specialized training & education on specific therapeutic areas or disease states. By offering these services, we navigate the complexities of clinical research, optimize trial operations, & accelerate the development of new & innovative therapies.