Helping Emerging Biopharma Navigate Performance, Partnerships and Compliance

Helping Biopharma Companies Navigate Performance, Partnerships and Compliance

teamSvg
In The News


TriRadial
Solutions Recognized for Contributions to BioNTech COVID-19 Vaccine

Learn more
teamSvg
In The News

TriRadial Solutions Recognized for Contributions to BioNTech COVID-19 Vaccine

Learn more
Our Focus

We help rapidly growing biopharma companies build the internal capabilities needed to scale globally

Our Focus Picture (2)
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 bring a unique combination of skills and perspectives to help our clients grow rapidly and improve the value delivered by vendors

 

This combination provides:

  • Process solutions to transform vendor relationships
  • Metrics needed to drive accountability
  • Tools and techniques tailored to your environment
  • Valuable lessons learned about quality and compliance

 

Unique Image

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.
bottom Left Circle
Domain Areas

We are solely focused on Life Sciences

We provide specific solutions to help biopharma and medical device companies position their R&D capabilities for scalable growth globally
Clinical

Clinical

In today’s changing clinical landscape, companies are increasingly pressured to do more with less and are looking for new and innovative ways to leverage data
icon (5)

Quality

The ability to demonstrate a fully functioning Quality Management System remains the single most important element of a company’s operations
icon (3)

Regulatory

Biopharma companies are facing an increasingly dynamic and complex regulatory environment, especially given evolving regulations in emerging markets
icon (4)

Safety/PV

Companies need the ability to collect, analyze and communicate safety related information, both internally and externally, with speed and integrity
Typical Challenges Across Development

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

  Clinical Quality Regulatory Safety/PV
Performance
  • 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
Partnerships
  • 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
Compliance
  • 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

 

rightSolution svg
Example Solutions

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

Process and Procedure Development
VendorSight 360: Vendor Selection and Governance
Audit and Inspection Readiness
Analytics, Metrics and Dashboards
Vendor Oversight
CAPA Optimization and Skill Development
tr-casestudy-06
tr-casestudy-07
tr-casestudy-08
tr-casestudy-09
tr-casestudy-10
tr-casestudy-01
tr-casestudy-02
tr-casestudy-05
tr-casestudy-03
tr-casestudy-11
tr-casestudy-12
tr-casestudy-13
tr-casestudy-04
tr-casestudy-14
tr-casestudy-15
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

Quality Systems Fact Sheet
Vendor Oversight
Building World Class CAPA Skills
Process-driven Compliance
Audit and Inspection Readiness
Fact Sheets

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

Download Fact Sheet
Download Fact Sheet
Download Fact Sheet
Download Fact Sheet
Download Fact Sheet
teamSvg
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.

Leo Dodds 2022
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
Fran Culver
Pasi Piitulainen 2022
Ulrike Geier
Featured Experts

Leo Dodds

New Jersey, USA

Quality and Compliance, Vendor Oversight

One of TriRadial’s earliest team members, Leo Dodds brings three decades of quality and compliance and operational experience from the life science industry to advise clients:

  • Quality and compliance leading practices (all GxP, but with a focus on GCP/GVP)
  • Creation of fit for purpose Quality Management Systems
  • CAPA leading practices, with a focus on CAPA for non-quality professionals
  • Key Performance Indicator development and integration
  • Executive oversight
  • Helps organizations develop and maintain robust Inspection Readiness capabilities

More about
Leo Dodds

Ramon (Ray) Rodriguez

Florida, USA

Procurement

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
More about
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
More about
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
More about
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 
More about
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
More about
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
More about
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)
More about
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
More about
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
More about
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)
More about
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
More about
Matt Hendricks

Frances (Fran) DeGennaro-Culver

Florida, USA

R&D Quality Assurance

Quality leader with a 30-year career of hands-on experience within clinical quality management, Fran specializes in: 

  • Developing and implementing U.S. and international clinical programs
  • Regulatory and quality strategies for R&D (regulatory submissions and inspections)
  • Clinical research
  • Clinical operations
  • Quality management (QbD)
More about
Frances (Fran) DeGennaro-Culver

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
More about
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
More about
Dr. Ulrike Geier
teamSvg

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.

Learn more
rightSolution svg
Contact Us

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.

 
Fill Form Below

Solutions to help navigate global growth challenges

Featured Solution: VendorSight 360™

End-to-End Vendor Selection and Governance
Click here