Our company open house was not only a fun networking event but also an exciting opportunity to get professional headshots.?? At Blue Parachute, we’ve got your back. Our dedicated team is here to support clinical operations needs for pharma and biotech companies of all sizes. We take pride in helping our clients navigate the world of clinical operations and land safely.? A huge shoutout to our amazing photographer, Cecile Hollinshead, for capturing such great headshots of the attendees.? Curious about our team and what we do? Check out our website to learn more!?blueparachute.com? #BlueParachute #SafeLanding?#ClinicalOperations #WomenInPharma #Networking #AnnArbor #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency
Blue Parachute Group
生物技术研究
Ann Arbor,Michigan 528 位关注者
Need a trusted team to ensure your clinical trial's data and documents are high quality? Blue Parachute has your back!
关于我们
Your Clinical Data and Documents deserve a #SafeLanding. At Blue Parachute, we've got your back! - Have you outsourced your pivotal clinical trial to a CRO and think your study data quality might be in jeopardy? - Do you seek an independent monitoring oversight team to review your clinical data and identify potential risks to your program? - Do you think your trial master file (TMF) would survive a Regulatory or Due Diligence audit? We listen to your program's pain points and pitfalls, propose ways we can help to de-risk your program. We have expertise within pharmaceutical and biotech companies making sure their critical programs stay on track. The Blue Parachute group is composed of clinical and industry individuals: many with over 25 years of experience.
- 网站
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https://blueparachute.com/
Blue Parachute Group的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- Ann Arbor,Michigan
- 类型
- 私人持股
地点
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主要
3390 Travis Pointe Rd
Suite C
US,Michigan,Ann Arbor,48108
Blue Parachute Group员工
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Robin Schmidt
Clinical Operations Excellence | Strategic Leadership | Outsource Management | Risk Mitigation | Process Improvement
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Shellie Cholke
Dedicated to Helping Clients Find Solutions and Solve Pain Points | Leader in Business Development, PV & Med Info, RA Specialty Services | Enthusiast…
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Lauren McGillicuddy
Clinical Research Consultant
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Scott Holmes
Physician Assistant - Emergency Department at Michigan Medicine
动态
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At Blue Parachute, we take pride in being an all-female-led business focused on empowering intelligent, strong women to excel. We foster collaboration and community, bringing together like-minded women to support and uplift one another. We're here to help companies navigate their challenges and celebrate victories.?We believe that when women support other women, incredible things happen! Let’s continue breaking barriers, making an impact, and building relationships and businesses that last! #BlueParachute #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency
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Is your data or TMF feeling a bit too spooky this Halloween? Let Blue Parachute’s expert team be your ghostbusters! We can help lay those fears to rest! After all, your data and documents deserve a fright-free zone!??? #HappyHalloween #BlueParachute #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency?
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?? Thrilled to Celebrate the Launch of Our Blue Parachute Office! ??? It was invigorating to unveil our new office space and introduce our team of expert consultants in clinical operations! Our new environment is tailored to foster collaboration and creativity, enabling us to better serve our clients and drive innovation.? A heartfelt thank you to everyone who joined us for the celebration! For those who couldn’t make it, we invite you to drop by soon for a tour and to connect with our community.? Looking forward to fostering new relationships and exciting opportunities!? #BlueParachute #SafeLanding #OfficeLaunch #Innovation #Collaboration #Networking?
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Are your study metrics telling the whole truth? Do you see all “green lights”? It’s crucial to ensure that your study metrics accurately reflect the true status of quality data and monitoring at your sites, rather than masking any underlying issues.?The Blue Parachute team specializes in: ? Thoroughly reviewing your data and monitoring plan to identify any hidden gaps, trends, or issues in current study metrics. ? Ensuring that 'green lights' are truly indicative of a smooth and effective process that reflects quality and completeness. Don't let misleading metrics jeopardize your trial's success. Gain peace of mind knowing that your data is accurate and complete. Let us help ensure your trial has a #SafeLanding! #BlueParachute #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency?
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Is your study’s Oversight Plan rock-solid? In the fast-paced world of clinical research, ensuring every detail is meticulously managed is crucial. Do you have a comprehensive Vendor Oversight Plan in place? Are you confident that your vendors are delivering top-notch work? At Blue Parachute, our expert team of research professionals are here to help! We specialize in:? ? Reviewing your Oversight Plans to identify and address any gaps.? ? Conducting oversight visits at participating sites to evaluate study data and monitoring activities.? If you’re seeking reassurance that your trial is on track and progressing as planned, let us provide the support you need. Your study deserves a safe landing! #BlueParachute #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency?
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In just 9 short months, Blue Parachute has soared to new heights and is still climbing! We’re thrilled to announce that we’re now partnering with 8 incredible clients and working on 20 projects through our expert services. Our dedicated team of research professionals is expanding rapidly, and through our collaboration with Premier Focus Solutions, we’re consistently exceeding deliverables and surpassing client expectations. A huge thank you to our amazing Blue Parachute team and clients for making this journey so rewarding. Here’s to many more milestones ahead and continuing to provide a safe landing to our clients! #BlueParachute #SafeLanding #Biotechnology #BioPharmaceutical #ClinicalDevelopment #ClinicalTrials #ClinicalOperations #Pharmaceutical #ClinicalResearch #Protocol #DrugDevelopment #ClinicalMonitoring #ClinicalDataManagement #RegulatoryAffairs #Oncology #Diabetes #Cardiovascular #ClinicalTrialEfficiency?
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?? Proud Sponsor of the MJR Foundation Champs Tailgate Fundraiser ?? Blue Parachute was honored to sponsor the Miles Jeffery Roberts (MJR) Foundation Champs Tailgate Fundraiser this past Friday, supporting mental health and suicide prevention within youth athletic communities. Our team didn’t just show up — we rolled up our sleeves! During the day, we volunteered to help with event preparations, and later, we gathered for an impactful evening to support this incredible cause. A special mention to our colleague, Kristen Roberts, who founded the MJR Foundation after her son died by suicide in 2017. It was a privilege to stand with her and champion this critical cause. ?? #MentalHealthAwareness #YouthSupport #SuicidePrevention #MJRFoundation #CommunityInvolvement #BlueParachute #SafeLanding
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In today’s clinical trials, sponsors are increasingly leveraging the TMF Reference Model to optimize their TMF setup and organization. This model offers clear benefits, including:? Standardization and Consistency: Ensuring uniformity across clinical trials.? Enhanced Efficiencies: Streamlining TMF management processes.? Increased Compliance: Good Clinical Practices and regulatory requirements.? Greater Transparency: Facilitating clearer and more accessible documentation.? Smoother Audits and Inspections: Simplifying the audit process with well-organized files.? But one crucial element that’s often overlooked is the manual review. While electronic systems and placeholders are desirable for managing TMF documents, a thorough manual review remains critical for the following quality checks:? Ensuring Completeness and Accuracy: Verifying that all essential documents are complete and accurately filed? Facilitating Timely Filing: Identifying and addressing document submission delays or issues.? Detecting Gaps: Uncovering missing or incomplete documents that automated systems might miss, which includes document cross-checks.? Don’t let automated TMF processes overshadow the importance of manual oversight. Meticulous manual reviews will elevate your TMF health and ensure your clinical trials are audit-ready and compliant.? Are you curious how a manual review can enhance your TMF processes? Contact Blue Parachute today to discover how we can help you achieve optimal TMF health.? #BlueParachute #SafeLanding #ClinicalTrials #TMF #TMFRescue #GCPandRegulatoryCompliance #TMFReferenceModel #ClinicalTrials #TMFManagement #RegulatoryCompliance #ClinicalTrialOptimization #ManualReview?
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Say hello to the Trial Master File (TMF), your clinical trial’s best friend in compliance with Good Clinical Practice (GCP) and regulations! The TMF is chock-full of clinical trial essential docs that allow regulators to dive into the details of your trial and data quality. A well-curated TMF makes audits and inspections a breeze, cuts down on inconsistencies, and ensures smooth sailing across trials. No matter the scale of your trial, a stellar TMF keeps everything clear and transparent—even after the trial is over. Mastering your TMF is the key to trial success. Your friends at Blue Parachute are experts in TMF gap analysis and rescue. Leap with us and land safely with a successful TMF! #BlueParachute #SafeLanding #ClinicalTrials #TMF #TMFRescue #GCPandRegulatoryCompliance?