As a quality consultant, one challenge I frequently observe, especially in small CROs and biotech companies, is the extensive outsourcing of key activities due to limited internal infrastructure. Outsourcing becomes problematic when vendors are engaged informally, often based on recommendations from partners or personal networks, without a proper qualification process. Fast forward a few months (or years), and you may discover that the service provider is not fit for purpose, jeopardising compliance, quality standards, or project delivery. So how can companies avoid this? ✅ Have a clear, pragmatic SOP for Service Provider Identification, Selection, and Management. ✅ Implement a robust due diligence process when evaluating new providers. ✅ Develop and maintain a Vendor Management Plan that includes regular performance reviews and re-qualification. 💡 Early structure saves future headaches. A solid vendor management framework is not about adding bureaucracy, it’s about making informed, auditable, and quality-driven decisions. How does your organisation ensure service providers remain fit for purpose over time? #clinicalresearch #qualitymanagement #outsourcing
Outsourced delivery model challenges
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Summary
Outsourced delivery model challenges refer to the difficulties companies face when relying on third-party vendors or partners to handle key business operations, such as logistics, IT services, or compliance processes. These challenges often include risks related to quality, communication gaps, scalability, regulatory oversight, and operational resilience that can impact overall project success.
- Select vendors carefully: Commit to a thorough qualification and due diligence process before choosing any outsourced provider to avoid costly mismatches and compliance issues.
- Monitor performance regularly: Put a structured vendor management plan in place that includes ongoing reviews, requalification, and clear communication to ensure the external team continues to meet your standards.
- Prepare for disruptions: Build flexibility and contingency plans into your outsourcing strategy to reduce risks tied to geopolitical events, fast growth, and supply chain volatility.
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Oddbox's 𝗕𝗶𝗴𝗴𝗲𝘀𝘁 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗛𝘂𝗿𝗱𝗹𝗲𝘀 as we 𝘴𝘤𝘢𝘭𝘦𝘥 & How We Cracked Them Scaling a business isn’t just about creating demand. It's about managing it. It’s about whether your 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 can keep up. At Oddbox, we hit some severe growing pains as we scaled from a small operation to delivering thousands of boxes every week. Here are four of the biggest challenges we tackled - plus what we learned along the way: 1️⃣ 𝗖𝗮𝗽𝗮𝗰𝗶𝘁𝘆 𝗖𝗼𝗻𝘀𝘁𝗿𝗮𝗶𝗻𝘁𝘀: 𝗢𝘂𝘁𝗴𝗿𝗼𝘄𝗶𝗻𝗴 𝗢𝘂𝗿 𝗦𝗽𝗮𝗰𝗲 (𝗔𝗴𝗮𝗶𝗻 & 𝗔𝗴𝗮𝗶𝗻) We started small - packing boxes in a church hall. Then we moved to a shared warehouse. Then our own warehouse, Then we spilled over into our neighbour's warehouse We realised managing logistics in-house was a nightmare. The fix? Outsourcing to a contract co-packer. The lesson? What works at 1,000 customers won’t work at 10,000. Infrastructure has to scale in phases. 2️⃣ 𝗟𝗮𝗯𝗼𝘂𝗿 𝗦𝗵𝗼𝗿𝘁𝗮𝗴𝗲𝘀: 𝗙𝗿𝗼𝗺 𝗗𝗜𝗬 𝘁𝗼 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 At first, we packed boxes ourselves. Then we brought in contract packers - Hard work to find reliable staff! Then we transitioned to a dedicated co-packer for consistency. The fix? Balancing cost, control, and consistency. The lesson? Sometimes, outsourcing might be the best move at a certain phase of growth. 3️⃣ 𝗦𝘂𝗽𝗽𝗹𝘆 𝗖𝗵𝗮𝗶𝗻 𝗩𝗼𝗹𝗮𝘁𝗶𝗹𝗶𝘁𝘆: 𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗨𝗻𝗽𝗿𝗲𝗱𝗶𝗰𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Surplus produce isn’t predictable. One week? Too many tomatoes. Next week? None at all. The fix? Trust-based relationships with growers & a flexible model. The lesson? If your supply is unpredictable, design your business to embrace adaptability - not fight it. 4️⃣ 𝗛𝘆𝗽𝗲𝗿𝗴𝗿𝗼𝘄𝘁𝗵 𝗦𝘂𝗿𝗴𝗲𝘀: 𝗞𝗲𝗲𝗽𝗶𝗻𝗴 𝗨𝗽 𝘄𝗶𝘁𝗵 𝟲𝘅 𝗗𝗲𝗺𝗮𝗻𝗱 𝗶𝗻 𝘁𝗵𝗲 𝟲 𝗠𝗼𝗻𝘁𝗵𝘀 𝗖𝗢𝗩𝗜𝗗 𝗵𝗶𝘁. Orders jumped from 8,000 to 50,000 weekly boxes. The fix? Scaling logistics, packaging, and delivery - fast. The lesson? Even well-prepared businesses can break under rapid scale. Agile, open and high performing teams & flexible partners are crucial. Scaling isn’t a straight line. Every hurdle forced us to rethink, adapt, and become more resilient. Now your turn: What’s the biggest operational challenge you’ve faced? 👇 #startupoperations #startups #scale #entrepreneurship
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Yesterday’s military exchange between India and Pakistan is deeply troubling. First and foremost, my thoughts are with everyone directly affected by this escalation. But for those of us working in tech and global delivery, it also forces a broader reflection on the stability and resilience of the global outsourcing model. As tensions rise, I’ve already heard concerns from IT leaders: 🗨️ “Will our team in India show up for calls this week? What happens if the situation worsens?” This isn’t a new conversation — it’s been building over the past several months. The initial enthusiasm for outsourcing to India is fading. Recurring challenges keep surfacing: - Cost vs. Quality – The “more for less” equation often breaks down when hidden costs, delays, and rework begin to mount. - Cultural and Time Zone Gaps – What looked manageable on paper can become a real drag on productivity. - Geopolitical Risk – Today’s headlines only amplify long-standing concerns around continuity and operational risk. This has fueled two familiar perspectives: 1. “It’s not India – it’s the vendor.” There’s truth to that. But with high turnover and fierce competition for talent, the odds of misalignment increase. 2. “Outsourcing to Asia is a trap.” That’s too simplistic — but it’s clear that many companies are rethinking their global delivery strategy. Just this morning, two companies reached out about moving projects back to Poland or the EU. Not in panic, but because this conflict accelerated decisions they were already quietly considering. Even if the situation de-escalates quickly (I hope so!), it’s a reminder: companies aren’t just looking for cost savings anymore — they want resilience, alignment, and predictability. For regions like Central and Eastern Europe, this shift could mark a moment of rebalancing. Not because of a crisis — but because of a longer trend that the crisis simply brought into sharper focus. 👉 What’s your experience with outsourcing to India or Asia? 👉 Are you seeing similar shifts or risks in your industry? #IToutsourcing #Nearshoring #offshoring #Geopolitics #GlobalDelivery
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First it was “offshore.” Now it’s “RISE.” Different name. Same delivery gaps. In the 2000s, we rushed to outsource infrastructure and operations offshore. It sounded efficient. It looked good on the balance sheet. Until… • SLAs were missed • Visibility disappeared • And “coordination” became a full-time job Now, we’re doing it again — but this time it’s called “managed services,” wrapped in a cloud logo, and sold as “RISE with SAP.” What’s changed? Not much. • Requests still take weeks. • Visibility still suffers. • Teams still get burned trying to stitch together workflows across multiple vendors. The packaging improved. But the delivery model? Still allergic to automation. Still relying on humans passing tickets across silos. Still making your internal team the glue. We didn’t build automation into our outsourcing model the first time. And now we’re outsourcing again… without fixing the foundation. It’s not just about what you outsource. It’s about how much operational weight you’re still forced to carry. If your “RISE” feels more like a rerun… Maybe it’s time to ask why we’re still falling for the same pitch.
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𝐆𝐢𝐯𝐞𝐧 𝐭𝐡𝐞 𝐦𝐚𝐫𝐠𝐢𝐧 𝐩𝐫𝐞𝐬𝐬𝐮𝐫𝐞𝐬 𝐈’𝐦 𝐬𝐞𝐞𝐢𝐧𝐠 𝐚𝐜𝐫𝐨𝐬𝐬 𝐁𝐚𝐧𝐤𝐢𝐧𝐠, 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬, 𝐚𝐧𝐝 𝐈𝐧𝐬𝐮𝐫𝐚𝐧𝐜𝐞 (𝐁𝐅𝐒𝐈), 𝐦𝐨𝐫𝐞 𝐚𝐧𝐝 𝐦𝐨𝐫𝐞 𝐈𝐧𝐝𝐞𝐩𝐞𝐧𝐝𝐞𝐧𝐭 𝐌𝐨𝐫𝐭𝐠𝐚𝐠𝐞 𝐁𝐚𝐧𝐤𝐬 (𝐈𝐌𝐁𝐬) 𝐚𝐫𝐞 𝐥𝐞𝐯𝐞𝐫𝐚𝐠𝐢𝐧𝐠 𝐨𝐮𝐭𝐬𝐨𝐮𝐫𝐜𝐢𝐧𝐠 𝐭𝐨 𝐥𝐨𝐰𝐞𝐫 𝐜𝐨𝐬𝐭𝐬. 𝐃𝐨𝐧'𝐭 𝐟𝐨𝐫𝐠𝐞𝐭 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐫𝐢𝐬𝐤, 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞, 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬, 𝐭𝐡𝐨𝐮𝐠𝐡: 🔷 Make sure you’re doing proper sourcing due diligence on any outsourced vendors you’re considering. 🔸 Fly-by-night outsourced vendors aren’t going to cut it. They skimp on the basics to keep their margins reasonable, causing impacts to service delivery and relationship support. 🔸They also bring a “whole laundry list” of other potential risks, such as infosec and financial health. 🔸Sure, not all of them are bad, but why roll the dice with untested vendors, especially when there’s so much riding on it? Go with a Tier 1 or 2 provider you know can deliver real value with less headache. 🔷 As Everest rightly pointed out (see link in comments), just because you outsource, you can’t ignore ensuring compliance with regulatory obligations. Outsourcing isn’t a “set it and forget it” relationship. 🔸 It’s essential to demonstrate to regulators that appropriate levels of ongoing oversight are in place based on the risk the outsourced relationship poses. 🔸 This includes solid processes for vendor tiering and treatment strategies, ongoing risk assessments, change control (particularly with material changes in contractual scope), communication and governance routines, compliance monitoring, scorecards, performance oversight, corrective action, contingency planning, termination, and offboarding. 🔷 Regulators expect your outsourced provider to comply with applicable laws and regulations, just as they do you. 🔸 Therefore, ensuring your contracts are buttoned up and offer necessary protections is crucial. 🔷 With critical processes such as Risk and Compliance, I’d never advocate outsourcing an entire function. 🔸 Orgs must set guidance around their risk appetite and tolerance, which should help inform outsourcing strategies. --------------------------------- Would love to hear from my network, TPRM, and Risk\ Compliance folks... What's your take?