Across the pharmaceutical industry, the R&D process is not getting any easier. Companies are faced with challenging budgets and economic pressures, all while aggressive timelines to get new therapies to market to meet patient expectations continue.
This environment has led to increased reliance on partner CRO and CDMO companies to access the necessary services and scientific skills, knowledge, and innovation to remain ahead of competition — making the selection of a trusted, experienced partner even more important.
At Quotient Sciences, project management is central to every drug development program that we work on. No matter where the project is performed — whether it is a clinical pharmacology program or an integrated Translational Pharmaceutics® program that combines pharmaceutical sciences and clinical capabilities into a single program of work at either of our Phase I clinical units in Miami, FL or Nottingham, UK — our project managers help ensure customers have a consistent experience and maintain high standards of quality in project delivery.
How we approach project management for drug programs
Our approach to project management is focused on the needs of our customers, and our project managers act as advocates to ensure an on-time and successful project delivery. Our delivery through high-performing multidisciplinary teams is fundamental to project success. Each project manager helps integrate services across scientific functions, facilities, and vendor partners to coordinate a program as it progresses from milestone to milestone. Each customer benefits from a single point of contact who will partner them from project initiation through delivery and reporting, facilitating seamless transitions to subsequent development stages.
Our project managers are organized to lead cross-functional, multidisciplinary teams structure that provides consistency and accountability for the delivery of projects. Every customer has a dedicated project team, which provides continuity of interactions and accountability, direct peer-to-peer communication with technical experts, and program oversight to effectively manage time, cost, and quality.
All project teams are assigned a lead team member from each of Quotient Sciences’ functions. This ranges from formulation development and manufacturing to analytical development and product release, clinical operations, regulatory and quality, and data sciences. Additionally, pharma project managers work closely with our business development and scientific teams to ensure a smooth handover to operations and continued scientific support throughout your study.
They are also skilled at vendor management for third party services which may be required for the study, this takes some of the complexity and burden of managing multiple vendors off the customer and ensures a streamlined approach to clinical delivery.
Our agile, adaptive project managers embrace changing requirements while always looking ahead on how to best handle complex processes. For example, real time human PK data can sometimes take us in a direction we hadn’t anticipated. Our project managers can work with multiple functions such as formulation development, analytical, regulatory, manufacturing, screening, and clinical and medical teams to ensure that any amendments to the study design, formulations or exposure limits are managed in a smooth and compliant fashion with minimal impact to project delivery timelines.
Through effective scheduling, forecasting, and risk management, we aim to successfully develop products and expedite the delivery of new medicines to patients.
Project managers act as a central point of coordination, maintaining clear lines of communication and providing direct access to the individuals responsible for delivering each component of the program. As many of our project managers have joined the Project Management team via other operational departments in the business, they bring with them insider knowledge on how to get the best from the operational teams.
Above all, the customer is put at the center of our collaborative structure to ensure project continuity and milestones are met without delay. We strive to understand the customer’s way of working, their objectives, and needs and we appreciate the huge responsibility and opportunity being bestowed on us to support their drug program. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast.
With over 200 years of combined experience and hundreds of active programs in motion, our Project Management team is well-versed in navigating the challenges that come with early-phase development. A strong focus on planning, risk mitigation, and problem-solving has earned the trust of customers — more than 98% of whom choose to partner with us again. That repeat engagement reflects not only a high standard of execution, but also the confidence clients place in the teams leading their programs.
Customer feedback about our Project Management team:
- “I wanted to take a moment to thank you guys for helping us get the first patients dosed! Because of you we were covered in the London Times and STAT news this morning.”
- “Quotient PM is exceptional, one of a kind!! We couldn’t have asked for more.”
- “Excellent services, will definitely work with Quotient in future and highly recommend to contract Quotient for an excellent delivery on overall project timelines, cost, and quality.”
- “Thanks everyone at the Quotient team... we really could not have done this without you!”
- “Excellent support from the PM throughout the study until close out.”
- “Excellent! ...... Having her coordinate all the teams we can see the value she brings to the whole study.”
- “(PM) is very good at identifying risks and mitigating them. She did this without having to consult with us which was great.”
Contact us today to learn how our project management teams can help you minimize risks and simplify the drug development process.