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If you’re running a biotech company or managing a drug development program, chances are you’re working with multiple CRO vendors. And you’ve probably experienced that choosing a wrong vendor can cause delays, quality issues, and increased costs. To avoid potentially derailing the entire project, here’s our list of success factors to address from Day 1: 1️⃣ Detailed Contracts: Clearly outline deliverables, timelines, and budgets. 2️⃣ Regular Updates: Schedule frequent check-ins to discuss progress and issues. 3️⃣ Transparent Reporting: Establish regular reporting systems to track progress. 4️⃣ Mutual Trust: Treat the CRO as a partner, fostering collaboration. 5️⃣ Incentives: Recognize and incentivize good performance. 6️⃣ Cultural Fit: Ensure compatible working styles and values. 7️⃣ Performance Metrics: Set clear metrics and KPIs to monitor progress. 8️⃣ Regular Audits: Conduct audits to ensure compliance and quality. 9️⃣ Risk Management: Develop plans to identify and mitigate risks.

Study delays can significantly affect the overall success of a clinical trial project, especially when it comes to budget and resource allocation. As #ProjectManagers, understanding the 𝐞𝐜𝐨𝐧𝐨𝐦𝐢𝐜 𝐢𝐦𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 is key to proactive risk management and optimizing trial timelines.⁣ ⁣ 🔑 𝐊𝐞𝐲 𝐈𝐦𝐩𝐚𝐜𝐭𝐬:⁣ 𝟏. 𝐈𝐧𝐜𝐫𝐞𝐚𝐬𝐞𝐝 𝐂𝐨𝐬𝐭𝐬: Every delay leads to additional operational expenses—extended staffing, site management, and regulatory fees can spiral out of control.⁣ 𝟐. 𝐑𝐞𝐯𝐞𝐧𝐮𝐞 𝐋𝐨𝐬𝐬𝐞𝐬: Delays in drug approval push back market entry, affecting the return on investment (ROI) and potential revenue generation.⁣ 𝟑. 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐲 𝐂𝐨𝐬𝐭: The longer the delay, the more resources are tied up, preventing focus on future projects or innovations.⁣ 𝟒. 𝐑𝐞𝐩𝐮𝐭𝐚𝐭𝐢𝐨𝐧 𝐑𝐢𝐬𝐤: Extended delays may weaken Sponsor confidence, leading to strained relationships or lost business opportunities.⁣ ⁣ 💡 𝐀𝐜𝐭𝐢𝐨𝐧𝐚𝐛𝐥𝐞 𝐒𝐭𝐞𝐩𝐬 𝐟𝐨𝐫 𝐏𝐌𝐬:⁣ • 𝐑𝐢𝐬𝐤 𝐅𝐨𝐫𝐞𝐜𝐚𝐬𝐭𝐢𝐧𝐠: Identify potential bottlenecks early and implement contingency plans.⁣ • 𝐒𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫 𝐀𝐥𝐢𝐠𝐧𝐦𝐞𝐧𝐭: Keep stakeholders informed with accurate timelines to adjust expectations and minimize disruption.⁣ • 𝐃𝐚𝐭𝐚-𝐃𝐫𝐢𝐯𝐞𝐧 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧𝐬: Use real-time data to adjust project activities and allocate resources where they’ll have the greatest impact on preventing delays.⁣ ⁣ Delays are more than just scheduling setbacks; they are financially and strategically costly. By taking proactive steps, Project Managers can mitigate these risks and safeguard the economic success of the #clinicaltrials.⁣ ⁣  𝐖𝐡𝐚𝐭 𝐬𝐭𝐞𝐩𝐬 𝐝𝐨 𝐲𝐨𝐮 𝐭𝐚𝐤𝐞 𝐭𝐨 𝐤𝐞𝐞𝐩 𝐲𝐨𝐮𝐫 𝐭𝐫𝐢𝐚𝐥𝐬 𝐨𝐧 𝐭𝐫𝐚𝐜𝐤? ⚙️⁣ ⁣ #ProjectManagement #RiskManagement #PMBestPractices #EconomicImpact #clinicalprojectmanagement #drugdevelopment ⁣

𝗛𝗮𝘃𝗲 𝘆𝗼𝘂 𝗲𝘃𝗲𝗿 𝗼𝘂𝘁𝘀𝗼𝘂𝗿𝗰𝗲𝗱 𝘄𝗼𝗿𝗸 𝘁𝗼 𝗮 𝗖𝗥𝗢 𝗮𝗻𝗱 𝗮𝘀𝗸𝗲𝗱 𝘁𝗵𝗲𝗺 𝘁𝗼 𝗳𝗼𝗹𝗹𝗼𝘄 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗮𝗻𝘆'𝘀 𝗦𝗢𝗣𝘀? 📋 🖋️ 📋 As someone who has overseen vendors, here are some of the common challenges that I've seen arise with this approach: • Time and resources (and $$$) spent educating CRO staff on unfamiliar processes • Attempts to follow the new process lead to confusion and disruption of the CRO's standard workflow • Numerous unnecessary SOP deviations • Growing tensions between sponsors and CRO CROs have their own SOPs designed to meet regulatory requirements and adapt to different clients. Their cross-sponsor and study approach relies on consistent processes for enhanced efficiency. Before engaging a CRO, sponsors should of course review the CRO's SOPs. Trust in your choice of partner and allow them the autonomy to deliver results. While vendor management is essential ("trust but verify"), I think all parties would prefer to focus their energy on work quality versus workflow. Do you share my sentiment? If not, what do you believe is an important aspect to this decision? #projectmanagement #vendormanagement #clinicalresearch #clinicalstudymanager #CRO #CRA

This is a question I receive a lot: Are the Project Manager and Cinical Trial Manager roles the same? Well it depends. Some companies use the PM and CTM abbreviations interchangeablely. Other companies have both the CTM and PM roles. Here is a quick video on some of the key differences between the two. To view the full interview with myself and Nicole M. Palmer, MS , click here: https://lnkd.in/gJzVXReV To learn more about the CTM role, you can read this blog as well: https://lnkd.in/gJnPcr7k ##clinicalresearch #clinicaltrials

A Key Team Member (e.g., Functional Lead) transition, whether due to promotion, reassignment, or other reasons, can disrupt your meticulously planned clinical trial and throw a wrench into its delivery. Here is how to strengthen your oversight to minimize the impact and ensure a smooth handover: ▪ Knowledge Transfer Deep Dive: Facilitate comprehensive knowledge transfer sessions where the departing team member meticulously documents key processes, data access protocols, critical decisions, potential risks, and ongoing issues. This ensures clear communication and understanding of critical information. ▪ Double-Check Access: Verify the new team member has the necessary access to systems, databases, and communication channels to effectively fulfill their role. Delays in access can significantly hinder progress. ▪ Documentation Duo: Double-check that all critical documents and procedures are properly transferred and understood by the new team member. This helps identify any gaps in understanding and ensures consistent performance in the respective Functional Area. ▪ Close Collaboration: Schedule regular check-ins with the new team member to address questions, concerns, and ensure they are comfortable in their new role. ▪ Onboarding Amplified: Go beyond basic introductions. Facilitate in-depth training sessions with the incoming team member, including shadowing opportunities and Q&A sessions with the outgoing member. By implementing these steps, you can maintain project continuity, minimize disruption, and ultimately, ensure the continued success of your clinical trial. #clinicaltrials #clinicalstudies #projectmanagement #clinicalresearch #drugdevelopment

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I had an amazing experience presenting a webinar to the CRAConnect community on Monday this week. I discussed the roles of Quality Assurance and Monitoring, how these roles are different yet complementary to each other in practice, and how Clinical Operations teams and trial participants greatly benefit from strong Quality Assurance and Monitoring programs that enhance compliance, data integrity and subject safety. We also had a great Q&A session afterward with some really great questions and talked more about the quality assurance function and other topics that I'm very passionate about too, like professional development and taking charge of our careers. #qualityassurance #clinicaltrials #clinicalmonitoring

Big CRO vs Small CRO What's the difference If you're considering a Career in Clinical Project Management Here's What You Need to Know! 🟢 At Large CROs: • You'll dive deep into specific therapeutic areas or trial phases. • PMs manage large-scale trials spanning multiple sites and diverse patient populations. • You'll have access to advanced tech and standardized processes due to the scale. • PMs typically engage with high-profile pharmaceutical clients and navigate complex global regulations. • There is more of a focus on project management aspects due(overseeing tasks) to varied roles within the organization. 🟢 At Small CROs: • PMs wear multiple hats, handling diverse tasks and engaging directly in various trial aspects. • You're expected to adapt swiftly to changing project needs and market demands, demanding agility and resourcefulness. • PMs Directly liaise with clients, offering personalized and direct interactions. • You typically have more of an opportunity to gain a comprehensive understanding through exposure to various tasks. • Resources are often more limited, so creative problem-solving is a key attribute to highlight when interviewing Neither is better or worse. It depends on the preference Choose wisely based on your preference for specialization, adaptability, and direct client engagement. Your choice shapes your clinical project management journey! ________________ 👋 Looking for tips, tricks, and resources to help with your job search? → Follow #CGATips → Visit my profile page and hit [Follow] → Smash the 🔔 to be notified when I post → Subscribe tomy YouTube Channel for Weekly Video Tips → Need help? DM me! #ClinicalResearch #CareerPathways #ProjectManagementSuccess

Let us maximise your commercial success with our tailored recruitment and people strategies. It's why we're #TrustedToDeliver. #WeAreStarPeople #pharma #medtech #biotech #recruitment #outsourcedpeople

A Key Team Member (e.g., Functional Lead) transition, whether due to promotion, reassignment, or other reasons, can disrupt your meticulously planned clinical trial and throw a wrench into its delivery. Here is how to strengthen your oversight to minimize the impact and ensure a smooth handover: •   𝐊𝐧𝐨𝐰𝐥𝐞𝐝𝐠𝐞 𝐓𝐫𝐚𝐧𝐬𝐟𝐞𝐫 𝐃𝐞𝐞𝐩 𝐃𝐢𝐯𝐞: Facilitate comprehensive knowledge transfer sessions where the departing team member meticulously documents key processes, data access protocols, critical decisions, potential risks, and ongoing issues. This ensures clear communication and understanding of critical information. •   𝐃𝐨𝐮𝐛𝐥𝐞-𝐂𝐡𝐞𝐜𝐤 𝐀𝐜𝐜𝐞𝐬𝐬: Verify the new team member has the necessary access to systems, databases, and communication channels to effectively fulfill their role. Delays in access can significantly hinder progress. •   𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐃𝐮𝐨: Double-check that all critical documents and procedures are properly transferred and understood by the new team member. This helps identify any gaps in understanding and ensures consistent performance in the respective Functional Area. •   𝐂𝐥𝐨𝐬𝐞 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧: Schedule regular check-ins with the new team member to address questions, concerns, and ensure they are comfortable in their new role. •   𝐎𝐧𝐛𝐨𝐚𝐫𝐝𝐢𝐧𝐠 𝐀𝐦𝐩𝐥𝐢𝐟𝐢𝐞𝐝: Go beyond basic introductions. Facilitate in-depth training sessions with the incoming team member, including shadowing opportunities and Q&A sessions with the outgoing member. By implementing these steps, you can maintain project continuity, minimize disruption, and ultimately, ensure the continued success of your clinical trial. #clinicaltrials #clinicalstudies #projectmanagement #clinicalresearch #drugdevelopment