Helping Emerging Biopharma Navigate Performance, Partnerships and Compliance

Helping Life Sciences companies navigate growth to bring therapies to patients faster


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Domain Areas

We are solely focused on Life Sciences

We provide deep domain expertise to help biopharma and medical device companies navigate scalable growth globally

Clinical Development

Companies are increasingly pressured to do more with less and are looking for new and innovative ways to conduct clinical, regulatory and safety activities
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Quality & Compliance

The ability to demonstrate a fully functioning Quality Management System remains the single most important element of a company’s operations
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Medical Affairs

Biopharma companies are facing an increasingly dynamic and complex environment, especially in the Development to Commercial interface
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Sales growth via an effective Go-to-Market strategy and strong enabling commercial capabilities is crucial to a company’s long-term success
In The News

Solutions Recognized for Contributions to BioNTech COVID-19 Vaccine

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In The News

TriRadial Solutions Recognized for Contributions to BioNTech COVID-19 Vaccine

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New & Noteworthy


New & Noteworthy

Our Focus

We help emerging and mid-market life sciences companies accelerate growth

Our Focus

We help rapidly growing biopharma companies build the internal capabilities needed to scale globally and drive the best outcomes from vendors


Our Unique Perspective

We leverage deep domain expertise in each of our solutions to help companies scale globally


There is no substitute for
real-world global experience

Our domain experts have 20-30 years of experience each.  They bring relevant perspectives regarding emerging trends across the industry, what works and what doesn’t for specific solutions and how to successfully implement transformational changes needed to leapfrog the competition.
TriRadial One-Page Overview 2023
Typical Challenges Across Development

Below are examples of challenges our clients have experienced across the R&D space

  Clinical Quality Regulatory Safety/PV
  • Study start-up delays
  • Global process harmonization
  • Project Management alignment
  • Inspection readiness concerns
  • Inadequate CAPA oversight
  • Lack of global RIM or IDMP strategy
  • Central/regional hub alignment
  • Inefficient hand-offs internally and with vendors/partners
  • Unclear roles and responsibilities
  • Sourcing strategy
  • Negotiating and managing CRO contracts
  • Lack of governance structure/processes
  • Quality agreements missing/out of date
  • Lack of transparency to vendor quality
  • Inadequate vendor oversight
  • Adoption of new partnering model
  • No visibility to vendor activities
  • Safety Database incomplete
  • Demonstrating effective vendor oversight
  • Overlaps of sponsor and vendor SOPs
  • Missing quality KPIs
  • Training not effective and skills lacking across the organization
  • Gaps in validation SOPs and templates
  • Company core data sheets out of synch
  • Poor commitment tracking globally
  • Late AE’s and aggregate reports
  • Poor regional oversight
  • Transparency to risks lacking


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Example Solutions and Capabilities

We develop implementable strategies and practical solutions that are based on reality, not theoretical assumptions

Click on the links below to explore a few of the solutions and capabilities we offer to help you tackle complex issues and transform your operational performance

VendorSight360: Vendor Selection and Partnerships
Clinical Execution Readiness
Process and Procedure Development
Audit and Inspection Readiness
Analytics, Metrics and Dashboards
M&A Integrations and Divestitures
CAPA Optimization and Skill Development
Commercial Execution Readiness
Data Strategy and Architecture


Selected Case Studies

GCP Quality Inspection Readiness Assessment

A rapidly growing pre-commercialization biotech company has outpaced its ability to demonstrate effective quality oversight of its GCP activities. It needs a detailed review of its Clinical organization and Quality Management System including core processes, technology, and organizational structure. It specifically needs to review its capabilities in the face of ICH E6 R2 requirements for risk-based methods.

PV Inspection Readiness Assessment

A biotech company has just received its first commercial product approval. Anticipating an inspection, new leader of its Pharmacovigilance organization needs a quick and comprehensive assessment of current gaps, potential risks and ideas for tool improvements. Given that operational activities are largely outsourced to a vendor, its ability to demonstrate oversight of vendor activities is a critical to its inspection readiness under ICH E6 R2.

GxP Inspection Readiness Training

A fast-growing biopharma company has just been granted approval for its first commercial product. Most of the client’s team has never experienced a full non-GMP inspection.  They completed a gap assessment and are actively addressing findings. But the entire organization needs training and guidance on hosting the Health Authority and presenting itself as organized, competent and capable of answering any question that may arise with speed and professional calm.

Clinical Process Transformation

A mid-sized biotech company was focused on executing a global clinical pipeline but, like many emerging companies, had inefficient and disjointed processes. In addition, processes and teams were not fully grounded in GCP or other regulatory compliance needs. These challenges combined to make the development process cumbersome, inefficient and open to compliance risks.

Clinical Project Management Org and Process

A small, rapidly growing Biotech had several therapeutic assets moving to clinical development.  It faced challenges in strategic development decisions, CRO negotiations, and senior management information reporting. It needed a consistent means by which to manage and report, and to focus on the science without being encumbered by complicated tools. Timing was critical as some team members would soon be on leave and the company had yet to achieve its first approval.

Sourcing Strategy

A mid-sized biopharma company needed to identify internal activities that should be outsourced and implement an objective, defendable process to select preferred vendors that not only fit specific functional/study needs, but also represent best value for investment.

Vendor Selection Process

An emerging biopharma company had an inefficient and disjointed process for the selection of vendors to support study-specific activities, from service need identification through contract execution. They had difficulty aligning on needs and during the bidding process, leading to challenging bid comparisons and an over-reliance on Start-Up Agreements (SUAs)

Procurement and Vendor Management Staffing

A small biotech company did not have internal resources or capabilities to support Procurement and Clinical Vendor Management functions; the internal team was focused primarily on Study Design and Clinical Operations execution. These gaps in key business functions, coupled with a rapidly expanding portfolio, presented significant risks to timelines and the ability to manage critical vendor activities.

Vendor Governance and Oversight

A rapidly growing pre-commercial biotech company found it increasingly difficult to manage large-scale clinical trials being executed by two costly global CROs. The company needed a robust oversight process to handle the rapidly increasing volume of planned trials, since consistent processes, metrics and tool to ensure on-time and high-quality delivery did not exist.

R&D Merger Integration

A rapidly-growing EU-based biotech company purchased a US-based entity. The company needed assistance planning and leading integration activities to harmonize across all Development functions.  Some of the capabilities between the two entities were complementary, but they were interested in rapid integration globally, to align with their newly-developed strategy.

Contracting Process

A small growing Biotech was bringing its therapeutic assets to full clinical development.  Balancing the need to move through clinical development in a safe but agile manner while guarding the company’s assets and leveraging emerging relationships with strategic suppliers was proving a difficult balance, particularly as different stakeholders had distinct needs and perspectives.  The result was a protracted contracting process which generated confusion and slowed work progress.  All of this while ensuring suppliers met quality and compliance standards to ensure the validity of clinical results.

CRO Rescue

A biotech company with products in early clinical phases sought to reduce its spend with a large Contract Research Organization, while looking for options to replace with a lower-cost and more responsive CRO. The internal team has limited experience interacting with CROs and needs guidance to ensure a successful trial outcome.

Change Order Evaluation and Negotiation

A small biopharma company was expecting a large Change Order (CO) from it’s primary CRO on a Phase IIB global clinical program that was experiencing delays. The company had limited means by which to evaluate the CO, given a mix of performance issues and COVID-related delays in study start-up and recruitment, as well as cost overruns due to low initial estimates for investigator pass-through grants. 

Data Integrity Review

A global genomics data company is building out its core processes and go to market strategy. It must recognize and integrate key quality principles to reduce operational and compliance risk. It conducts its operations in Europe, Asia and North America and is subject to Data Privacy regulations across all jurisdictions. The goal is to make its processes robust and compliant everywhere it does business.

Invoice Accrual Process

Leading biotech customer with a growing pipeline, relying more heavily on outsourcing partners, needs a way to effectively manage and control portfolio spend and obtain clarity related to study level financials to inform business decisions.

Download Case Studies


TriRadial_FactSheet_Clinical Execution Readiness
TriRadial_FactSheet_M&A Integrations and Divestitures
TriRadial_FactSheet_Commercial Execution Readiness
Quality Systems Fact Sheet
Vendor Oversight
Building World Class CAPA Skills
Process-driven Compliance
Audit and Inspection Readiness
Fact Sheets


VendorSight360 is TriRadial’s proven methodology for ensuring all aspects of your vendor relationship are optimized. VendorSight360™ ensures effective oversight in all stages of the vendor cycle, which is essential to maximizing performance from your vendors while improving transparency and managing risk.

Clinical Execution Readiness

Ensure that your organization has the appropriate people, processes, procedures, partners, and systems in place to achieve successful clinical outcomes while avoiding delays and roadblocks that have become all too common in clinical research.

M&A Integrations and Divestitures

Leveraging our combined experiences, TriRadial’s M&A experts have developed a highly customizable and flexible framework and a comprehensive Integration Planning & Execution Playbook.

Commercial Execution Readiness

It can be a long journey on the path to commercialization of a product, but once there, how you establish and operate the commercial capabilities of your company can ensure their success or cause you to fail in reaching the full potential of that product.

Architecting a Scalable and Proactive Quality Infrastructure

A scalable Quality infrastructure can improve productivity, create a competitive advantage and help shift a company’s culture to one of proactive compliance

Ensuring Effective and Compliant Vendor Oversight in an Era of Increased Outsourcing

The need to demonstrate full awareness and control of key vendor activities and outputs is becoming more critical as outsourcing continues to increase.

Building World Class CAPA Skills

A structured CAPA framework can make the difference between continually fighting the same fires and solving problems effectively once to create sustainable solutions.

Process-driven compliance, right-sized for your organization

A streamlined, compliant process is only useful if the organization is able to implement it. Processes and SOPs should balance performance and regulatory compliance.

Developing a Proactive Framework for Audit and Inspection Readiness

A well-run inspection or audit, supported by a sustainable, integrated framework, can help reduce the severity of a finding or sometimes avert one altogether.

Fact Sheet Download

Our Team

The TriRadial Team

TriRadial Solutions is an advisory firm committed to delivering practical, high-quality People, Process and Technology solutions to help your business grow.  Our team of industry experts and seasoned management consultants can help assess where you are currently and navigate a path forward to building robust, integrated capabilities poised for scalable growth.

John Iannetta
Ken Light
Mike Vogel
Ray Rodriguez 2022
Meryl Wiernik 2022
Rick Sax 2022
Raphaële Mary
Mike Hagan 2022
Vickie Crocker 2022
Jon Carlsons_2022
Tomasz Kosieradzki 2022
Antonio Biancardi
John Klein
Matt Hendricks
Pasi Piitulainen 2022
Ulrike Geier
Featured Experts

Julia Love


Managing Director, Vendor Selection & Partnerships

Julia Love brings more than 30 years of life science outsourcing and contracting experience, working in both the sponsor and CRO side of the biotech business. Julia focuses on providing TriRadial clients with best-in-class services in:

  • Clinical strategic sourcing support (CROs, Central Labs, and Clinical Technologies) including vendor identification, selection, contracting, and ongoing management
  • Strategic partnership selection and MSA business terms negotiation
  • Governance development support services, including CRO/vendor relations management
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Julia Love

John Iannetta

New Jersey, USA

Commercial Operations, Process & Program Management

John brings over 20+ years of commercial leadership experience in the pharmaceutical and medical device industries with deep domain expertise in the following areas:

  • Commercial operations functional assessments, recommendations and implementations
  • Project/program management and process excellence
  • Commercial business transformation and M&A integrations
  • Organization design, change management and communications
  • Commercial technology & data assessments and harmonization
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John Iannetta

Ken Light

Pennsylvania, USA

Global Development Transformation

A consulting leader and advisor, Ken is passionate about modernizing the processes and tools used to bring new therapies to market.  Ken brings a broad perspective on current and future state processes and technologies used in drug development by sponsors, sites, CROs, and patients, and will lead a TriRadial team focused on:

  • Process Optimization and Strategic Planning
  • Digital Transformation and Data Architecture
  • Clinical Innovation (patient engagement, automation and DCTs)
  • Computer Systems Assurance and Regulatory Adoption 
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Ken Light

Graham McGibbon


Principal Consultant, Digital Solutions

Graham brings over three decades of experience in IT solution architecture, design and engineering to the TriRadial team.

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Graham McGibbon

Mike Vogel


Principal Consultant, Digital Solutions

Mike specializes in Software Architecture and Implementation of custom solutions and products, with experience in many domains and technologies.

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Mike Vogel

Ramon (Ray) Rodriguez

Florida, USA


Ramon (Ray) is a senior procurement consultant with deep expertise across a wide range of categories and processes including: 

  • Strategic sourcing, both direct and indirect procurement
  • Procurement (upstream and downstream procurement) and vendor strategy development, oversight and governance
  • Data management (lean digital processing, AI, RPA and NLU)
  • Manufacturing operations, supply chain, line and supplier management
  • Clinical program and project management
  • Finance
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Ramon (Ray) Rodriguez

Meryl Wiernik

California, USA

Clinical Outsourcing and Audits

Meryl has 35+ years in the biopharmaceutical industry and senior leadership for 20 years with proficiency in: 

  • Quality and compliance (quality audits and systems, GCP, SOP writing and training)
  • Business process optimization and cost reduction
  • Launched a full CRO service offering in expanding a single site company
  • Laboratory operations and management
  • Clinical services outsourcing, vendor strategy development, due diligence, oversight and management
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Meryl Wiernik

Dr. Frederic (Rick) Sax

Lincolnshire, UK and Florida, USA

Clinical Design and Strategic Product Development

Rick brings 30+ years of deep domain expertise in the following sectors:

  • Overall drug strategy and development using novel, innovative technology solutions (including AI) to improve pharmaceutical R&D efficiency and productivity
  • Clinical and program design
  • Medical Affairs (KOL management and Phase IV studies)
  • Regulatory strategy and operations
  • Quality and compliance (bioethics, GCP, audits)
  • Drug device
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Dr. Frederic (Rick) Sax

Raphaële Mary

Paris, France

Procurement and Vendor Outsourcing Management

Passionate about enhancing performance throughout clinical development, Raphaële has over 25 years of global biopharma knowledge in:

  • Strategic sourcing/procurement
  • Outsourced portfolio management
  • Vendor management, governance and oversight
  • Worldwide clinical development, operations and program/project management
  • R&D performance optimization
  • Quality risk management, GCP, SOP writing/process training 
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Raphaële Mary

Mike Hagan

North Carolina, USA

R&D Processes Optimization

Mike is an R&D transformation leader and trusted advisor with almost 30 years of life sciences qualifications in:  

  • Global regulatory strategy, operations and alignment
  • Process optimization and mapping
  • Drug and biologic development process transformation
  • Product license transfer authority
  • Medical Affairs (call center, MSLs)
  • Pharmacovigilance and Safety operations
  • Clinical technology development and program manager
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Mike Hagan

Vickie Crocker

North Carolina, USA

Strategy Development and Change Management

Vickie has 20+ years’ experience leading global teams through complex issues and transformations, both as an internal and external consultant.  She is a leader passionate about: 

  • Strategy development and management
  • Change management
  • Strategic initiative management
  • Cost management and workforce planning
  • Process improvement and automation (workflow)
  • Clinical development, operations and program/project management
  • CRO/COO services
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Vickie Crocker

Jon Carlson

North Carolina, USA

Clinical Operations, Finance & Strategy

Consulting professional with 20+ years healthcare and biopharma operations experience, Jon's qualifications consist of: 

  • Clinical development and operations transformation initiatives
  • Drug asset acquisition and due diligence
  • Site start-up optimization
  • Finance
  • Clinical data strategy
  • Vetting clinical research site infrastructure
  • Procurement and partnerships (contract negotiations, vendor governance, oversight, management, due diligence and strategy development)
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Jon Carlson

Dr. Tomasz Kosieradzki

Klaudyn, Poland

GCP Quality Auditor & Inspection Readiness

Tomasz is a GCP quality specialist with leadership savvy in:
  • Clinical site preparation for (EMEA, FDA) regulatory inspections (conducts training, pre-inspection GCP audits for Phase I to IV trials, acts as an inspector during mock inspections and sponsor's representative)
  • QMS optimization, including ISO-15189-2012 Medical Laboratories
  • GCP audits for Phase I to IV trials
  • CAPA resolutions and training
  • SOP writing
  • Gap analysis in clinical research and due diligence
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Dr. Tomasz Kosieradzki

Antonio Biancardi

New Jersey, USA

IT Architecture

With over a decade of R&D information technology intelligence, Antonio focuses on:

  • Enterprise project management systems (safety, CMS, regulatory, financial functionality)
  • IT solutions architect and software developer
  • Liaison between IT and the business
  • R&D-focused systems (e.g., CTM, global investigator DB, eConsent)
  • Master DM
  • Strategy, process optimization and mapping
  • R&D project and portfolio management
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Antonio Biancardi

John Klein, MS MBA

Ohio, USA

R&D Processes Optimization

A business process consultant with more than 30 years of life sciences experience, John’s core work includes: 

  • R&D transformation
  • Drug development: clinical trial optimization
  • Regulatory process alignment and harmonization
  • Global product transfer
  • Business process transformation through technology
  • Regulatory affairs strategy and operations
  • Quality/compliance (GCP, GVP, SOP writing, SOP training/process training)
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John Klein, MS MBA

Matt Hendricks

Pennsylvania, USA

Strategy, Facilitation and Team Effectiveness

Matt is a strategic management consultant with over 15 years’ experience in:

  • Business design challenge sprints (focus on consumer base, fit for client need)
  • Strategic decision facilitation and analysis workshops
  • Organizational change planning and execution
  • Clinical development and program management
  • Finance
  • Aggregate portfolio management and asset development
  • Technology and business capability architecture
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Matt Hendricks

Pasi Piitulainen

Basel, Switzerland

Finance and Procurement

With over 20 years’ experience in the global life sciences industry, Pasi is a deep subject matter expert in procurement and finance, specifically in:

  • Global R&D finance and analysis
  • Global R&D portfolio management
  • Budgeting, FPA process, tool development and implementation
  • Clinical outsourcing strategy development and implementation
  • M&A integration (direct and indirect procurement and supply) of acquired pharmaceutical production plant and supply chain into existing business
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Pasi Piitulainen

Dr. Ulrike Geier

Heidelberg, Germany

Clinical Project Management and Vendor Negotiations

Ulrike brings over 30 years’ experience in clinical research within CROs and the pharmaceutical industry in multiple therapeutic areas.  Her background includes: 

  • International project and portfolio management
  • Senior strategic and operational oversight of worldwide Phase II/III clinical trials
  • Senior relationship management between sponsors and CROs
  • CRO selection from proposal to budget and contract (MSA/SOW) negotiations
  • Ongoing budget oversight and Change Order negotiations
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Dr. Ulrike Geier

Meet Our Founder

A management consultant and entrepreneur focused on life sciences for over 30 years
Geoff Garabedian
Founder and President
Join Our Team

We are always on the lookout for seasoned professionals who share our passion for solving complex industry issues.

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The TriRadial team is ready to answer your questions

For more information on any of our solution offerings or questions about how we can help you transform your business, please e-mail us using the form to the right, or schedule a meeting with Geoff Garabedian below or feel free to call us anytime.

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