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The pharmaceutical and biotechnology (biopharma) industries keep expanding their Research & Development (R&D) activities along with their manufacturing sectors. Over the last 10 years, these companies are choosing more and more to outsource the management of their clinical research activities to Contract Research Organizations (CRO). The purpose of this is to best contain operational and infrastructure costs, but also gain access to therapeutic and clinical trial expertise.
While big and small biopharma companies are acting as ‘Sponsors’ responsible of the initiation, management and / or financing of their compounds/products’ clinical trials , CROs – ranging from large, international full-service organizations to small niche specialty groups – offer the sponsors the services needed to move a new drug or device from its conception to its marketing approval.
In order to efficiently collaborate together, interactions between sponsors and CROs require a set of relationship management and communication skills to align both visions and partnering styles within a trust atmosphere. When these components are partially missing, the interactions between sponsors and CROs can at times be inefficient due to the large degree of shared responsibility, unshared goals, lack of trust and miscommunication. This can considerably limit the potential to complete trials in an optimal, harmonized, efficient and fast way. Moreover, the challenge significantly increases when a sponsor works with several CROs and a CRO works with several sponsors, making the interactions look more like ‘battles’ rather than constructive communications.
The BeCRO – a professional non-profit association of Belgian CROs – inspired by such interactions, decided to celebrate its 10 (+1)-year anniversary in a dynamic and original model of event: a Battle!
Indeed, on 26 October 2021, sponsors and CROs representatives were invited to battle/debate rounds that addressed fundamental questions in co-managing clinical trials regarding Contract and Budget negotiation, Quality Management, Project Oversight and Management, Business Development & procurement, Resources and planning management etc.
Modis was a gold sponsor of the event also offering a ‘Quality boxer’ and a ‘Project Management boxer’ to the ‘arena’.
The four ‘CRO versus Sponsor’ battle rounds tackled discussions about the biopharma sector’s challenges, strategic and transformational changes but also governance and operational activities at both sides, making the interactions well animated, realistic with both convergent and divergent point of views.
1- Legal battle
In order to make the sponsor-CRO relationship a win-win, both legal representatives try to conclude a comprehensive agreement that cover both interests & liabilities prior to the clinical trial initiation. While wanting to align to each other’s’ goals, frameworks and development organizations, the agreements’ discussions can take up to 6-12 months, delaying the clinical trial start, impacting the companies’ budgets and ultimately frustrating both parties’ operational teams.
Given the fact that to date, sponsor and CRO interactions have been fraught with inefficiencies if not confusion and needless duplication of task ownership in many situations, agreements need to be thought through and discussed ahead of any collaboration between both sponsor & CRO teams. This to prevent issues arising and to cover all possible scenarios in the best possible interest of both parties.
2- Quality battle
Data quality, being the cornerstone of a successful clinical trial, needs to be provided according to Good Clinical Practice guidelines that ensures the protection of human rights for the subjects and assure the safety and efficacy of the newly developed compounds or products.
Thus, all parties agree on the key role both sponsors and CROs play in ensuring high quality clinical trials keeping in mind that well defining roles & responsibilities at both sides help preventing quality issues.
By properly implementing quality at early stages of newly developed compounds or products, quality gains can be developed progressively and at all levels according to the needs of the company with processes monitored by Key Performance Indicators (KPI). By aligning both quality systems, transferring quality objectives to CROs and assessing risks at very early stages of the collaboration, sponsors can prevent some potential quality issues to better ensure data quality and integrity as well as the subjects’ safety through all the stages of a clinical trial.
3- Project Management battle
To manage large pipelines while getting specific therapeutic experience, sponsors face inevitably a complex operating situation with multiple moving parts, requiring collaborations with CROs.
However, outsourcing clinical trials’ management to CROs has shown that the sponsor/CRO relationship is not always a win-win since both goals and their applications are not the same.
While sponsors seek to reduce costs, increase speed and agility and access specific knowledge and expertise, CROs focus more on strategic, financial, and operational business goals often related to their own entity. Thus, the same trial or project is managed differently at each side especially in terms of budget, timelines and deliverables leading to a traditional client/vendor-type relationship. CROs project managers bring up the fact that the relationship with the sponsor tends to lack trust and empowerment leading to confusion and frustration for both parties, while sponsors request CRO project managers to embrace the sponsor’s culture, system and goals and execute the project with high expertise and no complaints.
The situation becomes more complex when both the sponsor and the CRO need multiple partnerships that have each its own goals, processes, culture and lacks clear business and risk management plans for success.
4- Business Development/Procurement battle
To stand out from competitors, CROs tend to have significant marketing and business development (BD) groups and strategies that vary from one CRO to another in size, staffing and budget to meet the pressures of achieving the company’s financial goals and thus ensuring its success and sustainability.
To select a CRO out of many, sponsors have key criteria to fulfill regarding the CRO’s specialty, staffing capacity and proficiency, clinical knowledge and experience, accessibility, location and geographical coverage, qualifications and financial stability, level of responsiveness, and pricing.
Again, acting from two different perspectives, sponsors and CROs need to take time to build strong and high value relationships as an essential pre-step to optimize the partnership they need to have in order to succeed the clinical trial management and thus the goals for each party.
In conclusion, for the biopharma industry to expand and succeed in developing and marketing new compounds/products, it needs an efficient and harmonious collaboration with CROs where both parties work together successfully defining mutual goals, business processes, roles and responsibilities, but also assessing risks, monitoring KPIs, managing quality, getting the process right with adequate tools and building a strong relationship based on trust and transparent interactions.
To succeed, sponsors’ and CRO’s teams need to operate on a united front, not in battles, sharing goals and aligning processes to optimize the clinical trials management, reduce their costs and increase satisfaction and productivity among both sides of the teams.
We at Modis Life Sciences understand these challenges and take as our mission to help sponsors improve their customers’ and patients’ quality of life, delivering projects on time with agility and flexibility, offering customized solutions and enduring partnerships – on and off the sponsors’ sites.
– Karen Rizks, Project Delivery Manager