© Copyright Arriello Ireland Limited 2021

Project Management.Its critical role for pharmaceutical outsourcing success.

Affilliate 1 Affilliate 2 Affilliate 3 Affilliate 4

Client project management

Arriello project team

…

Arriello assigns an experienced, dedicated project manager (PM) and PM Deputy to every project with overall authority and responsibility for managing execution.

Instead of juggling multiple parties, as a client you will have one Arriello subject expert PM acting as your single point of contact throughout the project for all countries and services, substantially easing and streamlining the communication flow for your internal stakeholders.

Another valuable part of this centralized approach is consistency across all territories in a project, with continuous training and guidance on all local and global PV legislation and regulatory requirements.

All project team members (internal and/or subcontracted local partners) follow the same rigorous processes and report to same PM.

With an established “best practices sharing structure”, our PMs can implement more efficient ways of working throughout the project. Most importantly, our PMs work with you to provide the business and operational knowledge required to act as your strategic partner.

We know from our clients that the ability to work directly with a trusted subject expert PM, who can guarantee high responsiveness, excellent service, and timely actions/advice, always exceeds their expectations.

This multi-disciplinary approach is focused on the successful execution of your project.

2

Time management: Adherence to all timelines and milestones.

Problem solver: Source of solution to any project obstacles.

Effective communication: Contact for all project stakeholders.

Subject matter expertise: Guide and advise throughout projects.

Risk awareness: Anticipation of future risks and mitigation planning.

Focused on customer needs: Readiness to adapt to client requirements.

Project Management at Arriello.

Good project management and subject matter expertise is an essential requirement in all industries to ensure projects run smoothly, especially in pharmaceutical development.

The Life Sciences sector generally outsources its activities to meet increased resource requirements, often from an ever-increasing number of regulations, or to bring in expert knowledge to supplement, or act as, internal teams.

By outsourcing, clients can benefit from that expert external knowledge and experience that a service provider brings, and at the same time find the most cost-effective resource solution.

Typical project structure.

The key attributes of all our project managers.

33

The following activities are performed by the PMs in either the set-up phase, or during project maintenance and delivery:

� Maintain project overview, administration and management.

� Single point of contact and coordination for all stakeholders.

� Oversee financial aspects, track profitability.

� Resource planning to meet timelines.

� Assess project risks, mitigate any issues.

� Create and maintain Project Management Plan.

� Define and follow the project objective, budget and scope.

� Monitor compliance, performance and progress.

� Organize and participate in client and internal meetings.

� Coordinate training assignments.

� Align KPIs and responsibility matrix.

� Review documentation (JO, PSA, SDEA).

Seeing the bigger picture.

When outsourcing processes such as pharmacovigilance or regulatory affairs, companies typically focus just on core technical services, without necessarily investing in a supporting PM service. And this is why projects so often fail to meet their milestones and objectives as planned.

Keeping your project on track.

The success of any outsourcing project requires a streamlined and uninterrupted workflow, with a strong interface between the client and suppliers. Neglecting to engage a dedicated PM can easily lead to a lack of critical communication among project stakeholders, which ends up with missed deadlines and/or exceeded budgets.

Get it right from the start.

A dedicated PM’s local presence, together with their hands-on management of local suppliers, ensures your projects run smoothly, giving you complete helicopter-view oversight and control.

PMFinance

Regulatory VendorManagement

Quality Management

Pharmacovigilance

E X T E R N A L

P A R T I E S

I N T E R N A L

P A R T I E S

VendorsClients

Client Management

What do project managers (PMs) actually do?

Robust projectmanagement beyond outsourcing.

4

Client centricity.

Budget control.

Quality management.

Change management.

1

3

2

4

Advantages with a dedicated PM:When one PM has full oversight of all the services related to a client, the role is not split per service type which ensures smooth project governance.

Risks without a dedicated PM:If PMs are not dedicated to a client and simply work on a service, there is no oversight of a client’s projects which can cause communication issues and misalignments.

Advantages with a dedicated PM:A PM monitors the project budget, ensures adherence to it, and raises potential risks. This prevents unexpected cost changes.

Risks without a dedicated PM:Lack of financial control can lead to budget overspend and undetected risks.

Advantages with a dedicated PM:Quality issue analysis and the correct and timely escalation of nonconformities avoids repeated gaps and increases efficiency.

Risks without a dedicated PM:A lack of quality management oversight causes repeated project issues and prevents the possibility for improvement.

Advantages with a dedicated PM:Oversight guarantees better change management control.

Risks without a dedicated PM:Misalignment with tracking and the control of project changes can lead to unexpected delays and miscommunication.

8 reasons you need to use a project management model:

55

Resource allocation.

Team cooperation.

Risk mitigation.

Cross-department oversight.

5

7

6

8

Advantages with a dedicated PM:Advanced delivery planning and coordination of resources in a non-linear way keeps projects on track and avoids unnecessary delays.

Risks without a dedicated PM:Using resources in a traditionally linear way means deliverables are likely to be inefficient and will incur delays.

Advantages with a dedicated PM:PMs keep teams engaged to ensure not just delivery, but also great cooperation with the highest quality of work.

Risks without a dedicated PM:Work is reduced to just a check-list, and projects are delivered only to meet the basic requirements.

Advantages with a dedicated PM:PM oversight brings immediate escalation and risk mitigation measures.

Risks without a dedicated PM:Issues are not identified quickly enough and/or are seen too late to mitigate them.

Advantages with a dedicated PM:Oversight of multiple departments allows a streamlined and efficient connection between departments, and better consultancy for clients on different services.

Risks without a dedicated PM:A narrowly focused PM (on one service), does not know how to recommend or support the client with cross-functional improvement suggestions and activities.

6

Ultra fast project enrollment. We proposed to initiate kick off and start project governance with 6 weeks before project starting date.

Challenges with project oversight due to multiple provider involvements and missing PM on the client side.

We created a tailored documents which contains and describes project governance, specificity, communication and responsibilities matrixes.

Tight submission deadlines for RMP. We set a responsibilities matrix at the beginning on the project, align responsibilities with client.

Country scale-up from 14 to 80 countries. We efficiently transitioned the project in a streamlined manner, ensuring uniformity, speed, global coverage, centralisation and consolidation – all to agreed timelines.

Readiness for go live day – client was not ready with all countries and created weaves/clusters, which would have led to inefficient usage of time and resources.

1) We developed a tailored solution for setting-up country enrolment using a Country Questionnaire and a Country Implementation tracker.

2) We proposed overlapping clusters to effectively manage resources and decrease project set-up time.

3) We prioritised countries with robust PV legislation which were more likely to be inspected.

Previous project challenges. Solutions.

Ensuring project success.Communication and responsiveness are critical to how we operate and approach working with all organisations, large or small. Our aim is to create the most efficient solution possible for our clients within each project situation. That means regular updates and dialog to ensure everybody understands next steps, expectations, milestones and timelines. And of course everything we do is to ISO:9001 standard, which together with our faster, better, smarter culture, creates real benefits for our clients.

A few examples of some project challenges, and our solutions:

Barry Rice

Project Management Director, ICON Plc, Ireland

7

Bespoke solutions, delivered.

I’m very excited to lead this great team that strives to ensure all client’s needs are addressed. The PM department has a client oriented approach with a strong continuous improvement mindset.

Our goal is to close the gap between all stakeholders by actively listening to the needs and ensuring that these are translated in the outstanding services delivered in the Arriello style – faster, better, smarter.”

Sergio Costa

Project Management Director

I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. Your professional conduct has been exemplary and I am truly grateful.”

ICON Plc

Global headquarters

Arriello Ireland LimitedNo. 51, Bracken Road, Sandyford, Dublin D18 CV48, IrelandPhone: +353 1 293 6755

European operations

Arriello s. r. o.Olivova 2096/4, 110 00 Prague 1, Czech RepublicPhone: +420 222 367 765

USA office

Arriello USAOne Marina Park Drive Suite 1410Boston, MA 02210, USAPhone: +1 617 807 7016

www.arriello.com

Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. We’ve been making the development-to-market process faster, better, and smarter since 2008.

Our global services span the product life cycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions.

Headquartered in Ireland, with operations across Europe, we consult and create solutions across the EU, North America, LATAM, CIS, MENA, Asia, and South Africa.

With our extensive global network, decades of combined experience and ISO:9001 certification, we are a trusted partner primarily to pharmaceutical and biotech companies.

Our valued clients rely on our ability to deliver, however complex their requirements, through our proven expertise, global coverage, and technology.

ISO 9001 certified

About us.

Service inquiries: sales@arriello.com

linkedin.com/company/arriello_group

From development to market. Faster. Better. Smarter.