Project Management and PMO Implementation

We help Pharmaceutical, Biotechnology, and Medical Device companies get their complex projects done right. At Treximo, our certified professionals partner with company leaders to get their projects done right and allow them to focus on what they do best.

Formerly Praxis Life Sciences

There is a Lot of Money at Stake if Your Projects Don’t Deliver on Time

Our certified professionals bring a proven, structured approach to deliver your projects successfully. Our project leaders are skilled at getting the rest of your organization on board with doing the project. We address risk management, issue management, as well as write charters, project plans, and communication plans, etc. for your project.

We Are Leaders in Project Management

Workshops to Plan Your Projects

You shouldn't have to continually monitor and adjust resources and money and explain to sponsors why their project might be off track. You should have experts guide you through the planning process to get a reliable timeline for your project that allows you to focus on your main responsibilities throughout the project.

Get a Reliable Timeline - Let's face it, most of us are too optimistic in our timeline and resource estimates. Our facilitators will guide your group through open discussions that will account for areas at risk so that you can get a realistic and achievable timeline.

Identify Critical Risks & Develop Mitigation Strategies - When unmitigated risks appear, projects can easily derail. The workshop discussions identify critical risks so that your group can determine how to avoid them or lessen their impact.

Get Better Team Synergy & Buy-In - With the help of our facilitators, your team develops their project plan so they’re immediately bought into it. The learning and discovery that goes on in this intensive 2-3 day workshop enable the team dynamics to be developed, too.

You leave with a reasonable, executable plan; they leave with a good understanding of their team's strengths and risk activities.

Get Higher Quality Results With Project Management That Ensures Success

You shouldn't have to spend hours of your day in project meetings when you've got more important things to do. You can be a leader that management trusts to get things done and have time to focus on your main responsibilities.

Get Project Managers Who Actually Lead - Some companies have "project managers" who simply schedule meetings and take meeting minutes. That is not who we are. Our Project Managers actually lead our clients.

Improve Your People, Processes, & Tools - We provide Project Managers with the experience to get projects completed right the first time. Our PMs will show your team how to use the project management processes and tools to improve efficiencies and operate at maximum potential.

Get Better Visibility to All Projects - You'll have insight into all of the projects in your portfolio, which will enable you to make better decisions for your organization. You'll finally know that your team is doing the right projects.

Our experienced, certified professionals bring best practice project management methodologies to your project.

Be a PMO Leader Who Gets the Right Things Done - Implement a PMO or Improve Your Existing Processes.

PMOs should alleviate frustration around managing multiple projects, not magnify it. You shouldn't have to lose sleep over poorly managed projects or haphazard project selection. You should have experts help you put in place a PMO framework that ensures you are doing the right projects while allowing you to focus on your main responsibilities.

Get a Framework & Tools That Enable Proactive Actions - Our implementation experts will set up a PMO framework and help you select the tools that are right for your organization.

Objective Project Prioritization Decision-Making - Everyone wants their project to get done, but how do you choose? We help you set up a mechanism to objectively prioritize projects to get the best use of finances and company talent.

Visibility Across Your Project Portfolio - No one likes to get blindsided by problems that could have been avoided. We'll work with you to select the right tools that give you the visibility you need across your project portfolio.

We know what it's like to answer to multiple executive sponsors who all want to know why their project isn't getting done. Get a PMO in place that eliminates your stress and worry.

We Manage All Kinds of Projects

The First Phase of the EU MDR is Required to be in Effect by May 2021 — Are You Ready?

(MDR 2017/745) will impact how medical devices are regulated and monitored in the EU. This will bring changes such as:

  • Reclassify devices and assess impact on revenues and margins
  • QMS impacts, increased notified body powers, key regulatory resource accountable
  • Enhanced traceability, UDI systems, assess impacts to economic operators
  • New clinical investigation and evaluation regulations
  • Enhanced post-market surveillance and vigilance processes
  • Change in label requirements, instructions for use requirements, and impacts to packaging

We Can Build the Structure - We will create a PMO structure to successfully drive your EU MDR effort. Our team will work with you to define "done" for the effort, develop project plans for each workstream, drive project progress, and keep all of the teams closely aligned.

We Have the Expertise - We have successfully and efficiently driven our client through all of these activities and are currently awaiting to complete the notified body audit (upon their certification). Our team can build quality documents and update your medical device manuals.

We Have the People - We bring Project Managers who are versed in EU MDR, core project management leadership, medical devices, and Quality/Regulatory principles. Our subject matter experts have deep, cross-functional knowledge.

You shouldn't have to figure out EU MDR alone. At Treximo, our experts can help you navigate the changes in regulation..

The First Phase of the IVDR is Required to be in Effect by May 2022 -- Are You Ready?

(IVDR 2017/746) will impact how in vitro diagnostics are regulated and monitored in the EU. This will bring changes such as:

  • Reclassify in vitro diagnostics and assess impact on revenues and margins
  • QMS impacts, increased notified body powers, key regulatory resources accountable
  • Enhanced traceability, UDI systems, assess impacts to economic operators
  • Enhanced diagnostic test performance requirements
  • Increased expectations and requirements for post-market surveillance and vigilance processes
  • Updates in label requirements, instructions for us requirements, and packaging impacts
  • Increased involvement of notified bodies

We Can Build the Structure - We will create a PMO structure to successfully drive your IVDR effort. Our team will work with you to define "done" for the effort, develop project plans for each workstream, oversee/drive project progress, and keep all of teams and key stakeholders closely aligned.

We Have the Expertise - We have successfully and efficiently driven our clients through all of these activities and are currently awaiting to complete the notified body audit (upon their certification). Our team can build quality documents and update your medical device manuals.

We Have the People - We bring Project Managers who are versed in IVDR, in vitro diagnostics, core project management leadership, and Quality/Regulatory principles. Our subject matter experts have deep, cross-functional knowledge.

You should not have to figure out IVDR alone. At Treximo, our experts can help you navigate the changes in regulation.

Gain Expert Software Validation Consulting and Compliance Audit Services.

Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. We help you:

  • Get your SQA policies, procedures, and validation templates in place fast.
  • Perform an Audit Readiness Assessment to show you where you're compliant - and where you're not. We will also deliver a prioritized action plan, so you can be ready on time.
  • Perform audits to your software vendors on your behalf.
  • Enhanced post-market surveillance and vigilance processes
  • Assess your company's systems for compliance with 21 CFR Part 11 or Annex 11, identify any gaps, and work with you to develop a remediation plan.
  • Identify process improvements and incorporate risk-based practices into your methodology.
  • Provide CSV and SQA expertise on a retainer basis, so you only pay for the guidance you need.

In addition to our consulting and compliance audit services, we have developed educational courses and webinars that help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects to maximize the impact of your compliance and quality efforts.

Having the Right Team is Crucial to Your Project’s Success

Project durations can range from a few weeks or months to years long.  The right team makes all the difference to your success. We make sure you get the right project leader. That's why we expertly match the perfect person or team of people to get projects completed right the first time.

Save Time, Money, and Headaches — Get Started Today.

With the Help of Our Certified Professionals, You Will:

  1. Get better visibility into your projects so that you can properly prioritize company resources to the most mission-critical projects.
  2. See your team chemistry and morale improve because projects start and end. And,
  3. Apply best practice project management methodologies across your entire organization.

Working with Us is Seamless. Here is the Plan

1. Schedule a Call

Pick a date and time that works for you, and schedule a brief introductory call with one of our experts about your project and goals.

2. Have a Meeting

Tell us about the challenges you are facing. We want to understand what type of support you are looking for so that we can determine which solution would be most helpful.

3. Receive a Customized Plan

Based on your needs, we will develop a tailored action plan that will define the next steps that will help you reach your project-related goals.

We Have Successfully Delivered Projects for Clients in These Areas

Regulatory

Quality

Information Technology

Product Development

Clinical Development

Global Medical Affairs

Health Economics and Outcomes Research

Pharmacovigilance / Drug Safety

Example Projects Include

Adverse Event (AE) Safety Systems Implementation

Signal Management Process Development

Established and Set-Up PMO

Risk Based Monitoring (RBM) Processes and Enabling Technology

Take Your Projects to the Next Level with Treximo.

Why Choose Treximo’s Project Management?

0+

Successful projects

0+

Unique clients

0

Years of experience

5 Reasons Projects Fail (And How To Prevent Them)

Many leaders are overwhelmed by their daily activities. So when they are tasked with additional special projects, they make unforced implementation errors that derail their projects, cost them lots of money, and cause resource burnout. In our short guide, we will show you how to make sure this doesn't happen to you.

5 Reasons Projects Fail Whitepaper Treximo

We Know Efficiency

Our project execution methodology creates superior results. We use Lean Six Sigma-focused techniques that drive transformation and enable us to plan, perform, and take your operations to the next level. Our client delivery teams are dynamic and remain highly responsive to the changing needs of your organization as they grow and develop.

We Can Handle Anything

We have unparalleled knowledge of the Life Sciences value chain. Our experts work with Pharma, Biotech, and Medical Device firms because that’s what we know best. Based on our advanced business management credentials and practical solutions, we provide best-in-class consultation for the top global companies.

We’ve Got the Experience

We have over 20 years of experience and an impressive track record leading life sciences companies’ projects. We partner with our clients and our process includes having clients tell us about their project needs, and together, we develop a tailored approach to project success.

We Have the Leadership

We are proactive partners, committed to your future. We serve as trusted advisors with an extensive track record in developing effective leadership strategies that have a far-reaching impact. Our comprehensive services work in concert to help you operate at maximum potential by resolving broad-scale functional issues and by enhancing broad-reaching departmental synergies.