Company
a Biotech client

Responsibility
1. Support integration of China into ongoing Global studies cross indication
2. Support trial operations for processes cross indication on compound level

Period
1. Q1-21 ongoing
2. Q4-22 ongoing

Project
@1.

• Establish project RACIS
  cross function, tri party Biotech-China Partner-Global CRO
• Support Biotech operations in establishing process with China partner to integrate China as country into the studies.
• Act as liaison for China partner for operational questions
• Facilitate and support China partner for HRG submission of vendor documents.
• Act as point of contact and coordinate bioanalytical discussions and local China lab set up together with contracting department.
• Support operations until China is fully up and running as country in global studies.
• Develop more detailed Lessons Learned for future projects.

Outcome

• China participates successfully in selected global projects.
• RACI for global studies created, with routine review.

@ 2. Routinely represent trial operations for cross-indication related process set up and questions.

SuccessFactors:
@1. Timely set up of China as participating country in 4 global trials. Timely set up of China only studies
@2: Timely roll out of process and rules as required by trial operations for cross-indication questions.

Company
HiRO – Chinese based CRO, providing service to Alira Health
CRO business

Responsibility
Clinical Operational due diligence of an Italian based CRO as candidate for acquisition.

Period
Q1 2021 – closed.

Project
The focus of the DD was to evaluate the Italian CRO operational (specifically Data Management, Statistical analysis and Clinical/Project Management capability and capacity as a full-service CRO.

Outcome
Report provided in Q 1, providing overview on Corporate Structure and PM Holding, Process and Systems and licencing, Management and Staff availability and experience in Operations (DM, Stats and Clinical), Quality management system and issue management, as well as defining assets and risks.

Success factor: Due Diligence Report provided in time, acquisition progressed and closed.

Company
Karwoth GmbH
CRO business

Responsibility
Reorganising the full budgeting process to allow simple tracking of service completion and addition of service.

Period
Q3 2020 – ongoing

Project

• Review and refine the existing budget to standardize budget creation across projects.
• Review and refine standards for rates and units
• Create easy to use excel basic tool to review and adjust budget as required, with transparency for easy client review.

Outcome

• Budget tools standardized cross projects
• Standard set to recalculate budget and change in scopes if required.

Success factor: 

• Budget revisions can be completed now within 1-3 day for review instead of 2 week
• Change in scopes, including inflation adjustments were easily accepted by client as budgets were logic and transparent.

Company
Karwoth GmbH
CRO business

Responsibility
Build simple QM structure and processes to support business in a small boutique CRO and be set up for vendor selection audits.
Establish standards for staff hiring training and retention.

Period
Q3 2020 – ongoing

Project

• Defining and creating of a fit for purpose Quality Management System.
• Reviewing, defining, and creating SOPs to support Process and quality management.
• Creation of Project Management Tools in line with new SOPs
• Establish CAPA process in line with new SOPs.
• Establish a standard process for hiring including competency-based interviews.
• Establish Training CV and tracking.
• Establish standards for communication and training.
• Creating Job descriptions and contract standards
• Management and strategy support for Business Owner
• Review and re-organise budget tools.

Outcome

• Quality Management systems and related SOPs and process established.
• Staff Training CV template established, implemented, and monitored.
• Standard training routine established and rolled out.
• Support for preparation, conduct, and reporting of two inspections

Success factor: two vendor capability inspection by two new clients, investigating process in line with GCP and standards successfully passed. Inspections successfully prepared, managed, and closed. Hiring process routine supported hiring of required new staff. Training compliance of staff 99%.

Company
Parexel GmbH
CRO business

Responsibility
Build management team, structure and processes to run a clinical operations leader department in EU,

Period
Start Q2 2009, time to deliver 6 weeks for new department structure, 3 months for SOPs

Project

• The building of a new department for Clinical Operations Leaders (COL) to guarantee standardization in competencies, training, and development for staff across Europe.
• Build within 6 weeks a solid structure to allow staff to move out of the current clinical department under the new COL department without disruption of ongoing business the staff was assigned to.

• The project included the creation of a new set of competencies, new job descriptions for all potential levels, including managers, and deciding on SOP building or integration into existing SOPs and completion of this latter task.

Outcome

• 350 staff successfully transferred from clinical operations into the new department respecting local labor laws within 6 weeks.
• 27 competent managers selected and hired from the EU wide clinical operations Management group within 6 weeks.
• SOP integration into Clinical Operations SOPs within 3 months

The whole process did not result in any disruption of projects, no exchange of staff was needed. All staff agreed to move to the new department.

Success factor “staff turnover”: zero turnover after transition and onwards all-time low turnover for staff (below 5%) and LMs (below 1%). Department structure still in place after 10 years.

Company
Parexel, GmbH 
CRO Business

Responsibility
Build a capacity planning structure for the Clinical Operations Leaders Department to manage and forecast resources efficiently
Integration into existing sales and proposal processes and requirements.

Period
Time to deliver 6 months

Project

Planning capacity 6-12 months in advance to ensure staff availability on time and in line with project forecast
Expertise in profile tracking of staff, respecting data protection laws to match staff with project requirements

The project included building a sustainable technical platform as well as a team structure to manage the review and assignment going forward.

Outcome

• Lotus notes DB build and data for all 350 staff and project assignments entered
• Forecast capacity planning build in for 6, 9, and 12 months
• Interfaces with relevant sales platform (clientlink) integrated for an early alert on new projects
• Interface with project view build-in to feed project real start and end dates
• Experience DB rebuild and data of 350 staff entered
• Team recruited and trained to maintain and manage data, consisting of 1 Lead Resource Manager and 3 Junior Resource Manager
• Process build for routine weekly resource review
• All department managers trained on the new resourcing process to provide updates to the resource management team weekly

Success factor: 

Capacity planning for the COL group was in line with project needs and 12 monthly accurate forecasts available.
Assignment matched project needs, positive feedback from sales
The COL resourcing office served as a role model for the company to build a companywide Project Resourcing Office 5 years later.

Company
Parexel, GmbH 
CRO Business

Responsibility
Build a knowledgeable team of managers in Clinical Operations, capable of understanding the pricing tools and provide strategic and pricing relevant input into client proposals representing WW Clinical Operations.
Ensure alignment with existing sales and proposal development processes and requirements.

Period
Time to deliver 3 months

Project

• Alignment of expectations with the proposal development group and workload estimation based on monthly scope of proposals.
• Definition of the resourcing requirement (non-dedicated LM) 
• Selection of interested and skilled ~40 LM and SLM across clinical Operations
• Training definition, building & roll out
• Establish ongoing mentoring

Outcome:

• The Clinical Reviewer group was set up globally within the timeframe of 3 months
• Proposal reviewer assignments build into sales project for an automated request of clinical proposal reviewers WW
• Defined, described, and agreed with sales clear scope for clinical input
• Training material created and delivered training on contracting, pricing tool algorithms, and cost drivers, and proposal text. 
  • Initial training delivered to all reviewers WW
  • 6 weekly forums were established to provide ongoing training and lessons learned.
• Established ongoing mentoring contacts at a senior level in ClinOps/Sales WW for reviewers to provide quick support. 

Success Factors:

Selecting clinical operations LMs for proposal review enhanced the quality and strategic approach of proposals and as “site effect” enhance the financial knowledge in the LMs group

Company
Parexel, GmbH
CRO Business

Responsibility
Create a robust, not tasked based pricing model to support pricing and resource planning for clinical operations leaders.

Period
Time to deliver 2 months.

Project

• Develop a pricing model that enables pricing for COL resources.
• Scalable from single country / single site to WW studies / > 500 sites
• Include adaption for pricing during study start-up and conduct of a clinical trial

Outcome:

• An adjustable model developed, scalable by countries and sites.
• Robust to provide pricing and resource forecast for all type of studies in Phase2-4

Success Factors:
The model has proven successful in terms of pricing and resourcing for about 10 years, allowing alignment of resource needs to project requirements and execution in the budget.