Signant Health’s Post

TMF Tips for Success Here are some golden nuggets: 1) Tech Savvy: Leverage eTMF systems for better organization and accessibility. Embrace the digital transformation! 💻 2)Training Advocate: Continuous learning is key. Stay updated with the latest trends and best practices in TMF management. 🎓 3)Detail Detective: Pay attention to the little things. Minor errors can have major impacts, so be meticulous. 🕵️♀️ 4)Proactive Planner: Plan ahead to ensure all TMF documents are complete and accurate before deadlines. Time management is crucial! 🗓️ Working in the TMF isn't just a job, but an art form. Share your tips and experiences below! Learn more here: https://lnkd.in/gUMU2-xm * * * #TrialMasterFile #ClinicalResearch #ClinicalTrials

“We genuinely appreciate your entire team being so approachable, friendly, and collaborative.” When onboarding new customers, this is something we strive to hear! We at DRS pride ourselves on excellent customer service and collaborating with our customers to make the partnership experience beneficial to all parties. Managing a clinical study requires constant operational support and dedicated staff. Using a skilled vendor with SME’s can bring peace of mind to both sponsors and CRO’s. Here are some things to look for in your eTMF vendor selection: -        User friendly software with service levels to match -        Ongoing document QC and filing with experienced CRA’s at the helm. -        Oversight reporting of study metrics to help gauge the inspection-readiness of your study -        Guaranteed service levels for compliance monitoring Often sponsors and CROs might find themselves questioning their vendors qualifications and are looking to make a change. DRS Corporation prides itself on offering services that exceed our customer’s expectations using our motto “Service with a Smile” 😊. 🌐 https://www.drscorp.com 📧 info@drscorp.com 💻 DM us for more information! #eTMF #TMF #clinicalstudy #datatransfer #datamigration #datamanagement #clinicaloperations #quality #documentcorrection #clinicaldatamanagement #clinicalresearch #clinicaltrials #service #servicewithasmile

“We genuinely appreciate your entire team being so approachable, friendly, and collaborative!” When onboarding new customers, this is something we strive to hear! We at DRS pride ourselves on excellent customer service and collaborating with our customers to make the partnership experience beneficial to all parties. Managing a clinical study requires constant operational support and dedicated staff. Using a skilled vendor with SME’s can bring peace of mind to both sponsors and CRO’s. Here are some things to look for in your eTMF vendor selection: - User friendly software with service levels to match - Ongoing document QC and filing with experienced CRA’s at the helm. - Oversight reporting of study metrics to help gauge the inspection-readiness of your study - Guaranteed service levels for compliance monitoring Often sponsors and CROs might find themselves questioning their vendors qualifications and are looking to make a change. DRS Corporation prides itself on offering services that exceed our customer’s expectations using our motto “Service with a Smile” 😊. 🌐 https://www.drscorp.com 📧 info@drscorp.com 💻 DM us for more information! #eTMF #TMF #clinicalstudy #datatransfer #datamigration #datamanagement #clinicaloperations #quality #documentcorrection #clinicaldatamanagement #clinicalresearch #clinicaltrials #service #servicewithasmile

“We genuinely appreciate your entire team being so approachable, friendly, and collaborative.” When onboarding new customers, this is something we strive to hear! We at DRS pride ourselves on excellent customer service and collaborating with our customers to make the partnership experience beneficial to all parties. Managing a clinical study requires constant operational support and dedicated staff. Using a skilled vendor with SME’s can bring peace of mind to both sponsors and CRO’s. Here are some things to look for in your eTMF vendor selection: -        User friendly software with service levels to match -        Ongoing document QC and filing with experienced CRA’s at the helm. -        Oversight reporting of study metrics to help gauge the inspection-readiness of your study -        Guaranteed service levels for compliance monitoring Often sponsors and CROs might find themselves questioning their vendors qualifications and are looking to make a change. DRS Corporation prides itself on offering services that exceed our customer’s expectations using our motto “Service with a Smile” 😊. 🌐 http://www.drscorp.com 📧 info@drscorp.com 💻 DM us for more information! #eTMF #TMF #clinicalstudy #datatransfer #datamigration #datamanagement  #clinicaloperations  #quality #documentcorrection #clinicaldatamanagement #clinicalresearch #clinicaltrials #service #servicewithasmile

“We genuinely appreciate your entire team being so approachable, friendly, and collaborative!” When onboarding new customers, this is something we strive to hear! We at DRS pride ourselves on excellent customer service and collaborating with our customers to make the partnership experience beneficial to all parties. Managing a clinical study requires constant operational support and dedicated staff. Using a skilled vendor with SME’s can bring peace of mind to both sponsors and CRO’s. Here are some things to look for in your eTMF vendor selection: - User friendly software with service levels to match - Ongoing document QC and filing with experienced CRA’s at the helm. - Oversight reporting of study metrics to help gauge the inspection-readiness of your study - Guaranteed service levels for compliance monitoring Often sponsors and CROs might find themselves questioning their vendors qualifications and are looking to make a change. DRS Corporation prides itself on offering services that exceed our customer’s expectations using our motto “Service with a Smile” 😊. 🌐 https://www.drscorp.com 📧 info@drscorp.com 💻 DM us for more information! #eTMF #TMF #clinicalstudy #datatransfer #datamigration #datamanagement #clinicaloperations #quality #documentcorrection #clinicaldatamanagement #clinicalresearch #clinicaltrials #service #servicewithasmile

⁉ What are we going to do with all this paper? ⁉ Throughout the span of a clinical trial, there’s a potential for a windfall of binders and a ton of paper. It’s helpful to have a good clinical data management team in place to help reduce your carbon footprint and get your TMF electronic! Moving paper to an electronic system gives sponsors and CROs a more efficient way to evaluate a study’s inspection readiness and an easy way to access study data at a moment’s notice. DRS has become proficient in these types of transfers and can host the studies either in the DRS eTMF or transfer to any host eTMF. Services we offer include:         📌 Scanning and certification         📌 Attribution and/or QC of document filing         📌 Oversight reporting        📌 Audit review We accept both closed paper studies for archive services, as well as ongoing paper studies with the option to electronically submit documents (hybrid study). Let us be your one stop shop TMF solution! Contact us for more information! 🌐 www.drscorp.com 📨 info@drscorp.com. 📝 Direct message us if you have any questions! #eTMF #TMF #clinicalstudy #datatransfer #datamigration #datamanagement #clinicaloperations #quality #documentcorrection #clinicaldatamanagement #clinicalresearch #clinicaltrials #service #servicewithasmile #scanning

Let's bridge the gaps in your CMC journey with DSI! 🚀 Our expert consultants are your partners in success, helping you navigate any CMC challenges. Whether it's a submission tune-up or a complete strategy overhaul, our CMC HealthChek™️ is your roadmap to triumph! 💪💼 Ready to move forward? https://bit.ly/3HWXsOy ✨🌐 #DSIConsultingMagic #CMCSuccess #NextLevelStrategy

Mastering Trial Master Files: Your Blueprint to Hassle-Free Mastery! 🚀 Explore the three vital stages: TMF process design, implementation, and maintenance, and discover how they can revolutionize your #TMF. Ready to embark on the path to TMF excellence? Read our blog here: https://bit.ly/48YZ3zc * * * #TrialMasterFile #ClinicalResearch #ClinicalTrials

I recently read Montrium’s 2023 State of TMF Industry Report, and I was SHOCKED to see some of the findings 😱 ...   According to the survey, 32% of TMF professionals reported the cost of implementation as the #1 impediment to making the shift to an eTMF system.   I was even more surprised to find that many of the TMF professionals who reported this were also paper TMF users. So, let's ask ourselves: is it cheaper to maintain a paper TMF than an eTMF?   Aside from all the office supplies and storage you'll need to maintain a paper TMF, there are so many other hidden costs that will not only hurt your company's bottom line, but also your TMF when it comes time for inspection. I’d also like to remind you that the work isn’t done once your drug or medical device is on the market. You still need to retain your entire TMF for 25 years after the fact. Now imagine making sure that your paper TMF stays secure and out of the elements for that entire period. The costs will certainly add up! But if you still believe that the financial barrier to entry is too burdensome, don’t worry—you're not alone. There is a general lack of resources out there to help TMF’ers make informed decisions about their options, but I really want to help shift the conversation to talk about the costs of managing a paper TMF. What are YOUR thoughts on the paper TMF vs. eTMF debate? I’d love to hear from you in the comments! And be sure to check out the Resource Center on the Montrium website to read the full State of TMF report for yourself! #StateofTMFReport2023