Working with traditional clinical research organizations (CROs) can be challenging. Ask anyone in the industry. Your priority is not always their priority, especially if the CRO is large. Or, they lack seasoned talent in key roles so, while well-intentioned, you have green, inexperienced personnel on your critical path…and often you won’t know it until it’s too late, if ever. It’s not just about getting the work done on time–it’s about getting it done right and at a reasonable cost. While you may transfer the tasks to a CRO, you do not transfer the responsibility to be compliant with regulatory law. That buck stops with you. How do you address this problem? Hire experience and govern the process. Assure quality metrics are in place and followed. Maintain expert oversight. Who can manage or support your CRO choices? aktaPD® can.
Our team of veteran pharmaceutical drug developers oversees and governs the multiple facets of a CRO, double-checking processes to ensure timely and accurate delivery on your goals, from preclinical to post-marketing phases. Our experts review budgets for accurate and fair pricing, assess comprehensive time lines, make sure key milestones and deliverables across groups are met, and liaise with departments and stakeholders, within and outside your company. aktaPD® experts help your CRO identify and resolve challenges, manage budgets, produce regular executive summaries, and present to shareholders and regulatory authorities.
When a CRO is deemed non-productive, the common reaction is to change CROs and start over. While that ultimately may be necessary, we say it’s not a blame game; it’s a lack of oversight and governance. Here’s what our team can achieve with expert governance:
- Significant reductions in budgets/bids by understanding industry standards, clinical trial design, and competition
- Proper team size and composition, internally and externally
- Company objectives on time or ahead of time
- Streamlined clinical operations strategies
- Financial prudence in dealing with the inevitable challenges along the development path
- Personnel retention and satisfaction, at both the CRO and your company
- Quality metrics to assure clean, reliable, and compliant study execution, data, and reporting
- Getting viable assets back on track after “disaster” recovery
Because we understand the complex development process and how best to oversee all the stakeholders you have retained to get your product to market, we can complement your internal team, or act as your internal team. A common saying is, “They don’t know what they don’t know.” Make sure you know. Contact aktaPD®.
Need an experienced, dedicated team who has your back and can support your CRO for success? Contact us.