CRO / CDMO Management

Managing outsourced projects especially at multiple locations is a challenging task.
We understand the business of outsourcing and act as a project management partner for sponsor organizations.

Our Expertise

Rxbiopro has proven expertise in managing outsourced projects on behalf of sponsors of varying size and complexity.

Discovery Project

CMC Projects

Clinical Development Projects

Regulatory Submission Project

Clinical and Commercial Manufacturing Projects

Quality & Regulatory Audit Projects

Advantage Rxbiopro

With demonstrated experience in managing projects for sponsor organizations, we help you manage every step of your outsourced projects.

Get access to a network of CROs / CDMOs – We help you in identifying potential outsourcing partners that fits your needs.

Make the screening process easy – Rely on our evaluation process to select an outsourcing partner which is fit for purpose.

Get the local support you need – Our project managers work locally with the CRO / CDMO and uphold the business interests of sponsor organizations.

Flexible working models – Hire our PMs which can provide virtual support or get them staffed at the location of your ongoing project.

Our Approach

Our project management strategy is tailor-made for managing each of the outsourced projects A qualified project manager engages with you at every step and follow through a set of processes

Effective information transition – It all starts with understanding the project scope, risk, interdependencies and key assumptions

Development of project roadmap – A high level roadmap is created to align expectations and project plan.

Compliance requirement assessment – Identifying country specific regulatory requirements and addressing them remains a critical component of the project plan.

Project planning and execution – a realistic project plan offering flexibility to adopt changes is created and tracked throughout the project life cycle.

Communication and alignment – A 360^o health check at regular intervals aligns the stakeholders for informed decision making.

How we ensure project success

We work for you to ensure the projects deliver the expected outcomes and value for money. While executing your projects we focus on

Reduction or elimination of avoidable delays – Quick preparatory work to ensure a faster project initiation. Continued focus on project acceleration opportunities.

Creative approach and anticipatory planning – Minimization of unforeseen and uncontrollable delays and costs through agile delivery approach.

Issue and risk management – Continued resolution of issues and risks to minimize impact on project delivery.

The more the projects you offer us to manage, the more successful we believe we are .

Case Study

Title – Marketing authorization for commercial manufacturing and supply of a novel biological (Title)

Objectives – A global biopharmaceutical company hired Rxbiopro as project management partner to manage a multi project program. The key objectives of the program were to demonstrate reproducibility of a manufacturing process as CDMO and filing marketing authorization applications with CDMO as a manufacturing site.

Rxbiopro Scope of Work – Rxbiopro extended its project management expertise to set up program roadmap, pay periodic visits to CDMO for assessing execution effectiveness, reporting to CXO suite stakeholders about the program progress.

Key benefits delivered – Rxbiopro worked with the key stakeholders of the CDMO and sponsor organization to perform all technical and regulatory work to file the marketing authorization application which was eventually awarded.

Let's Discuss Your Next Project

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Training Interventions

Help your project managers develop project management skills to lead large and complex projects. Explore our tailor made courses designed for pharmaceutical and biotechnology led organizations.