PHARALL provides regulatory, clinical trial planning, vendor oversight, and clinical program and project management services to biotechnology companies, helping them navigate the regulatory and clinical landscape to progress their product. Our experts offer strategic planning, budgeting, and risk sharing strategies to ensure timely completion of a high-quality study, with adequate oversight to ensure appropriate outcomes. The business cases below show how PHARALL’s experts address your business needs and produce measurable outcomes for you.
Clinical Strategy
- Regulatory & Clinical Trial StrategyOur expert network analyse the GAPs in your pre-clinical data, guide you through the regulatory landscape and prepare your regulatory submissions.
- FeasibilityFind the right sites and countries for your trial design. We support you with database and local expert intelligence to challenge and optimize your clinical trial execution plan. Adapt the trial design to the sites and local standard of care to meet and maximize your patient recruitment potential.
- Study Design Optimisation with AIArtificial intelligence and regulatory experts improve your clinical trial protocol. They identify risks, realize opportunities and increase the success probabilities of your clinical trial protocols based on expertise and historical data.
- Clinical Trial Budget SimulationYou get sound budget estimations for your clinical trial design based on industry benchmarks, budget databases, and real CRO ballparks. This enables you to include the financial aspects of your trial design in your overall strategic decisions. You are also prepared to understand what a reliable trial budget would be before you start evaluating vendors.
- ObjectivesWith promising in-vitro and in-vivo data, a biotech company seeks a GAP Analysis for IND and to develop a regulatory & clinical trial strategy. The goal is to have a consistent roadmap into clinic that is convincing for investors and collaborators.SolutionsPHARALL’s network of subject matter experts analyzes the existing data and develops an integrated development strategy. In a f2f workshop, a roadmap is agreed upon to achieve the next inflection point.OutcomesAn integrated strategy is read for execution including milestones for manufacturing, nonclinical, clinical development, interaction with competent authorities including timelines and costs.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.Testimonial“PHARALL has the right subject matter experts at hand to support you to reach the next inflection point”
- ObjectiveA mid-sized European biotech company was considering conducting a complex Phase 2 study to compare a new compound with a drug already on the market. With several CRO proposals that suggest different recruitment strategies and time-lines the challenge was to assess realistic patient recruitment rates and optimal site selection in different countries which was not biased by CROs goal to win a project.SolutionsIn cooperation with our specialized data-science partner PHARALL provided a country comparison and a standard of care map for each country. The insights showed that the comparison drug had been prescribed to the majority of patients in this group in selected countries and provided detailed recruitment rates for different countriesOutcomesOverall the client received an unbiased picture of the market landscape to better evaluate realistic patient recruitment rates and select countries based on real data. In addition investigators in two of the countries were identified who saw the study as a benefit for their patients. Another country was more centralized around a specific KOL whose engagement would be crucial for the study’s success.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
- ObjectiveA pharma company considered to optimize their generic draft protocols to avoid common mistakes, increase likelihood of trial success and optimize the protocol to reach a streamlined less complex study design.SolutionsIn cooperation with our specialized data-science partner the protocol was analyzed with a specialized artificial intelligence. Based on this data-driven outcome regulatory specialists interpreted the computed outcome and produced a guidance document to improve the trial protocol as expected by the client.OutcomesIn a retrospective analysis the outcomes of this AI-assisted approach the solution was able to identify of 75% of all real case issues which translates to 40% of budget savings and 2 years of timeline savings.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.TestimonialThis is a unique approach which can deliver the risk analysis results in an understandable language for study team.
- ObjectivesA Biopharma company wanted to evaluate the financial and timeline impact of different clinical trial scenarios to optimize for the best clinical strategy.SolutionsWith industry benchmarks and databases PHARALL accurately estimated the total clinical trial costs and recruitment time-lines based on historic data.OutcomeBy comparing different scenario simulations the client identified the optimal clinical strategy with the best balance between trial complexity, geographic reach and the lowest costs.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred license fees to utilize the benchmarking databases and tools.Testimonial“PHARALL gave us important insight in clinical trial costing and scenario estimation. Their presentation of their analysis was clear and easy to follow. We have now moved forward to working with the PHARALL Team in the RFP process for our upcoming clinical trial.”
VP of Clinical Operations, BioPharma, USA
Regulatory & Clinical Trial Strategy
Our expert network analyse the GAPs in your pre-clinical data, guide you through the regulatory landscape and prepare your regulatory submissions.
- ObjectivesWith promising in-vitro and in-vivo data, a biotech company seeks a GAP Analysis for IND and to develop a regulatory & clinical trial strategy. The goal is to have a consistent roadmap into clinic that is convincing for investors and collaborators.
- SolutionsPHARALL’s network of subject matter experts analyzes the existing data and develops an integrated development strategy. In a f2f workshop, a roadmap is agreed upon to achieve the next inflection point.
- OutcomesAn integrated strategy is read for execution including milestones for manufacturing, nonclinical, clinical development, interaction with competent authorities including timelines and costs.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
- Testimonial“PHARALL has the right subject matter experts at hand to support you to reach the next inflection point”
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Feasibility
Find the right sites and countries for your trial design. We support you with database and local expert intelligence to challenge and optimize your clinical trial execution plan. Adapt the trial design to the sites and local standard of care to meet and maximize your patient recruitment potential.
- ObjectiveA mid-sized European biotech company was considering conducting a complex Phase 2 study to compare a new compound with a drug already on the market. With several CRO proposals that suggest different recruitment strategies and time-lines the challenge was to assess realistic patient recruitment rates and optimal site selection in different countries which was not biased by CROs goal to win a project.
- SolutionsIn cooperation with our specialized data-science partner PHARALL provided a country comparison and a standard of care map for each country. The insights showed that the comparison drug had been prescribed to the majority of patients in this group in selected countries and provided detailed recruitment rates for different countries
- OutcomesOverall the client received an unbiased picture of the market landscape to better evaluate realistic patient recruitment rates and select countries based on real data. In addition investigators in two of the countries were identified who saw the study as a benefit for their patients. Another country was more centralized around a specific KOL whose engagement would be crucial for the study’s success.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
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Study Design Optimisation with AI
Artificial intelligence and regulatory experts improve your clinical trial protocol. They identify risks, realize opportunities and increase the success probabilities of your clinical trial protocols based on expertise and historical data.
- ObjectiveA pharma company considered to optimize their generic draft protocols to avoid common mistakes, increase likelihood of trial success and optimize the protocol to reach a streamlined less complex study design.
- SolutionsIn cooperation with our specialized data-science partner the protocol was analyzed with a specialized artificial intelligence. Based on this data-driven outcome regulatory specialists interpreted the computed outcome and produced a guidance document to improve the trial protocol as expected by the client.
- OutcomesIn a retrospective analysis the outcomes of this AI-assisted approach the solution was able to identify of 75% of all real case issues which translates to 40% of budget savings and 2 years of timeline savings.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
- TestimonialThis is a unique approach which can deliver the risk analysis results in an understandable language for study team.
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Clinical Trial Budget Simulation
You get sound budget estimations for your clinical trial design based on industry benchmarks, budget databases, and real CRO ballparks. This enables you to include the financial aspects of your trial design in your overall strategic decisions. You are also prepared to understand what a reliable trial budget would be before you start evaluating vendors.
- ObjectivesA Biopharma company wanted to evaluate the financial and timeline impact of different clinical trial scenarios to optimize for the best clinical strategy.
- SolutionsWith industry benchmarks and databases PHARALL accurately estimated the total clinical trial costs and recruitment time-lines based on historic data.
- OutcomeBy comparing different scenario simulations the client identified the optimal clinical strategy with the best balance between trial complexity, geographic reach and the lowest costs.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred license fees to utilize the benchmarking databases and tools.
- Testimonial“PHARALL gave us important insight in clinical trial costing and scenario estimation. Their presentation of their analysis was clear and easy to follow. We have now moved forward to working with the PHARALL Team in the RFP process for our upcoming clinical trial.”
VP of Clinical Operations, BioPharma, USA
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Vendor Selection & Management
- CRO selectionA transparent CRO selection process ensures you are engaging a vendor with the best expertise at a fair budget. A tailored CRO contract ensures smooth and predictable collaboration with your vendor.
- Project Management & Outsourcing ManagementDedicated experts support vour clinical trials with project management and vendor oversight. Be in full control of vour trial performance and project finances.
- Vendor Governance Vendor Project ManagementYou need a strategy and operational support to keep oversight of your vendors. We develop the vendor governance and oversight SOPs taylored to your organisation and our project managers have the experince to get your trial back on track.
- Budget ControllingA transparent and up to date project controlling framework enables you to always have project progress, invoices, budget burned and budget remaining in sight.
- ObjectivesA small biotech company was seeking an alternative vendor to conduct their phase 2 trial with their GMO. The main objective was to find a reliable CRO with relevant capabilities and experience at a more competitive pricing.SolutionsThe CROs in our PHARALL Alliance Network were experienced to conduct the challenging new clinical trial. Overall the client quickly identified 2 final vendors of equal capabilities with the experience to bring the project to a success at a lower budget.OutcomesThe project was outsourced at a far lower budget than originally envisioned. This was mainly possible due to choosing a smaller more specialized CRO.PHARALL Alliance BenefitsIn addition to the cost savings by choosing a different vendor, the client experienced additional discounts through the purchasing agreements of the PHARALL Alliance.Testimonial"Within the PHARALL Alliance we were able to successfully identify a specialized CRO to conduct our phase 2 trial. It was pivotal for us to identify a vendor which works with us in a collaborative way on the same eye level. We were very pleased about the robust budgets we received at a more competitive pricing due to the PHARALL Alliance terms.”
Juha Yrjänheikki, CEO Aurealis Therapeutics, Finland, Switzerland - ObjectivesA mid-sized biopharma company needs to additional resources to cover the outsourcing and vendor governance tasks for their upcoming clinical trials. An important expectation is that the consultants work within the team and have longlasting experience.SolutionsTogether with the PHARALL experts, the project needs were quantified and the relevant experience of consultants was defined.OutcomesPHARALL was able to provide interim support within weeks to seamlessly take over projects as needed.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.Testimonial"PHARALL has the right subject matter experts at hand to support your to reach the next inflection point"
- ObjectivesA biotech company has outsourced its trial to a full-service CRO. Now they want to implement the outsourcing and vendor governance processes needed to successfully manage vendors and project progress according to ICH/GCP.SolutionsTogether with the client, PHARALL developed an oversight model to demonstrate effective oversight to Health Authorities . This includes the identification of project KPIs, budget controlling, and vendor governance and escalation procedures.OutcomeRelevant SOPs are setup to effectively run operational and steering committees for vendor governance. KPIs are defined and agreed upon with CROs to measure project progress and quality. Trainings for company stakeholders ensure proper executionPHARALL Alliance BenefitsAs a PHARALL Alliance member, you are eligible to receive outsourcing and vendor governance trainings at a fraction of the costs.Testimonial"The key to success to your projects is a reliable partnership with your vendors. This does not arise by itself, but needs to be strategically planned and defined in strong business processes and measurable KPIs. This is the essence of Vendor Governance models."
- ObjectivesFor a phase 1 trial in oncology, the client wanted to implement robust budget controlling to monitor CRO expenditures and avoid unexpected CRO change orders. The key objective was ro make sure the costs remain within the signed CRO budget.SolutionsWith 18+ years of experience in CRO budget controlling PHARALL implemented with the CRO an easy-to-handle yet robust budgetcontrolling process to closely monitor the monthly services provided.OutcomeThis prevented an increase in costs of a midsix- figure amount at the study initiation phase. During the trial execution the client was able to identify potential cost overruns by the CRO before the CRO was aware of the issue.PHARALL Alliance BenefitsAs a PHARALL Alliance member you are always supported by a team of experts to make sure costs overruns are identified early on to implement mitigation measures. PHARALL provides inhouse trainings for clients and members to efficiently manage CROsTestimonial"PHARALL was pivotal for our most important trial to avoid CRO cost overruns and to negotiate and reduce unjustified CRO change orders. Their efficient budget controlling successfully avoided unjustified CRO cost increases. The investment in a collaboration with PHARALL pays off immediately and can be directly measured by realized cost savings through discounts and successful negotiations"
CFO of, BioPharma, Oncology Switzerland
CRO selection
A transparent CRO selection process ensures you are engaging a vendor with the best expertise at a fair budget. A tailored CRO contract ensures smooth and predictable collaboration with your vendor.
- ObjectivesA small biotech company was seeking an alternative vendor to conduct their phase 2 trial with their GMO. The main objective was to find a reliable CRO with relevant capabilities and experience at a more competitive pricing.
- SolutionsThe CROs in our PHARALL Alliance Network were experienced to conduct the challenging new clinical trial. Overall the client quickly identified 2 final vendors of equal capabilities with the experience to bring the project to a success at a lower budget.
- OutcomesThe project was outsourced at a far lower budget than originally envisioned. This was mainly possible due to choosing a smaller more specialized CRO.
- PHARALL Alliance BenefitsIn addition to the cost savings by choosing a different vendor, the client experienced additional discounts through the purchasing agreements of the PHARALL Alliance.
- Testimonial"Within the PHARALL Alliance we were able to successfully identify a specialized CRO to conduct our phase 2 trial. It was pivotal for us to identify a vendor which works with us in a collaborative way on the same eye level. We were very pleased about the robust budgets we received at a more competitive pricing due to the PHARALL Alliance terms.”
Juha Yrjänheikki, CEO Aurealis Therapeutics, Finland, Switzerland
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Project Management & Outsourcing Management
Dedicated experts support vour clinical trials with project management and vendor oversight. Be in full control of vour trial performance and project finances.
- ObjectivesA mid-sized biopharma company needs to additional resources to cover the outsourcing and vendor governance tasks for their upcoming clinical trials. An important expectation is that the consultants work within the team and have longlasting experience.
- SolutionsTogether with the PHARALL experts, the project needs were quantified and the relevant experience of consultants was defined.
- OutcomesPHARALL was able to provide interim support within weeks to seamlessly take over projects as needed.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
- Testimonial"PHARALL has the right subject matter experts at hand to support your to reach the next inflection point"
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Vendor Governance Vendor Project Management
You need a strategy and operational support to keep oversight of your vendors. We develop the vendor governance and oversight SOPs taylored to your organisation and our project managers have the experince to get your trial back on track.
- ObjectivesA biotech company has outsourced its trial to a full-service CRO. Now they want to implement the outsourcing and vendor governance processes needed to successfully manage vendors and project progress according to ICH/GCP.
- SolutionsTogether with the client, PHARALL developed an oversight model to demonstrate effective oversight to Health Authorities . This includes the identification of project KPIs, budget controlling, and vendor governance and escalation procedures.
- OutcomeRelevant SOPs are setup to effectively run operational and steering committees for vendor governance. KPIs are defined and agreed upon with CROs to measure project progress and quality. Trainings for company stakeholders ensure proper execution
- PHARALL Alliance BenefitsAs a PHARALL Alliance member, you are eligible to receive outsourcing and vendor governance trainings at a fraction of the costs.
- Testimonial"The key to success to your projects is a reliable partnership with your vendors. This does not arise by itself, but needs to be strategically planned and defined in strong business processes and measurable KPIs. This is the essence of Vendor Governance models."
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Budget Controlling
A transparent and up to date project controlling framework enables you to always have project progress, invoices, budget burned and budget remaining in sight.
- ObjectivesFor a phase 1 trial in oncology, the client wanted to implement robust budget controlling to monitor CRO expenditures and avoid unexpected CRO change orders. The key objective was ro make sure the costs remain within the signed CRO budget.
- SolutionsWith 18+ years of experience in CRO budget controlling PHARALL implemented with the CRO an easy-to-handle yet robust budgetcontrolling process to closely monitor the monthly services provided.
- OutcomeThis prevented an increase in costs of a midsix- figure amount at the study initiation phase. During the trial execution the client was able to identify potential cost overruns by the CRO before the CRO was aware of the issue.
- PHARALL Alliance BenefitsAs a PHARALL Alliance member you are always supported by a team of experts to make sure costs overruns are identified early on to implement mitigation measures. PHARALL provides inhouse trainings for clients and members to efficiently manage CROs
- Testimonial"PHARALL was pivotal for our most important trial to avoid CRO cost overruns and to negotiate and reduce unjustified CRO change orders. Their efficient budget controlling successfully avoided unjustified CRO cost increases. The investment in a collaboration with PHARALL pays off immediately and can be directly measured by realized cost savings through discounts and successful negotiations"
CFO of, BioPharma, Oncology Switzerland
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Quality & Change Management
- Change Order NegotiationsSafe costs with well-prepared change order negotiations. Change orders are no longer a source of negative surprises. Transparent payment schedules and change order processes make sure project changes translate to comprehensible and fair budget revisions.
- Rescue Trials Strategy & ExecutionClinical trials falling behind schedule benefit from our external view on your project challenges. We identify root causes of rescue situations, develop counter actions and execute rescue strategies.
- CRO Management and Clinical Outsourcing TrainingYou need a strategy and operational support to keep oversight of your vendors. We develop the vendor governance and oversight SOPs taylored to your organisation and our project managers have the experince to get your trial back on track.
- ObjectivesA small biotech company is facing a change order from its CRO. The cost increase is a serious burden for the finances and in some aspects, the increased budget appears to be unjustified by the services planned. The client seeks support in reducing the change order.SolutionsThe PHARALL team reviewed the change order budget and the performance of the CRO to date. Then the project progress and the service performance were recalculated based on the original assumptions and a negotiation strategy was developed to reduce the costs.OutcomesThe change order was signed at a 20% reduced total amount saving the client a seven-figure amount of trial budget.PHARALL Alliance BenefitsAs a PHARALL Alliance member, you are always supported by a team of experts to make sure cost overruns in change orders are compared with project progress and budgets agreed. PHARALL makes sure you are only charged for the services that are agreed upfront.Testimonial"PHARALL negotiated and reduced unjustified CRO change orders which saved us a 7-figure amount representing 20% of the CRO budget. The investment in a collaboration with PHARALL pays off immediately and can be directly measured by realized cost savings through discounts and successful negotiations"
CFO of, BioPharma, Oncology Switzerland - ObjectivesA small biotech company was unsatisfied with the trial performance in patient recruitment. The majority of sites declined to participate and recruitment rates were low in participating sites. The client experienced significant project delays and cost increases with no prospect of improvement.SolutionsTogether with the project teams, PHARALL facilitated a deep dive root cause analysis of the recruitment problem including analysis of site feedback and trial costs structure. The project teams then agreed to execute the developed turnaround plan.OutcomesRoot causes of low recruitment were identified and countermeasures were implemented. The project budgets were revised according to the new project plan and cost efficiencies were found in the new budget. The project is now on track to be completed as agreed.PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.TestimonialPHARALL has the right subject matter experts at hand to support your to reach the next inflection point
- ObjectivesA global pharma and biotech company has finished internal reorganizations and now needs to train its internal staff in vendor governance and clinical outsourcing. The objective is to train and align all stakeholders including clinical development, purchasing, legal and management.SolutionsPHARALL's has many years of experience in training biopharma companies to optimize their internal processes in clinical outsourcing. An interdisciplinary training agenda was setup and executed to cover all operational, financial and legal spects of clinical outsorcing.OutcomeOver 4 weeks and 4 different training sessions the client received an in-depth overview of the processes and best practices. In breakout sessions the client developed internal strategies to tackle the some of the important strategic questions.PHARALL Alliance BenefitsAs a PHARALL Alliance member, you are eligible to receive outsourcing and vendor governance trainings at a fraction of the costs.Testimonial"Very thorough course and informative." ... "Delivered with personality that kept everyone involved. He knew our roles/responsibilities." ... "Related relevant personnel experiences and how tools in the course were applied." ... "Presenter had good knowledge and examples for dealing with situations. The workshops were very engaging." ... "Clear presenter, slides clear and understandable."Clinical Outsourcing BootcampBook your Clinical Outsourcing Training here. Get it delivered virtually to your company as a tailored inhouse course.
Change Order Negotiations
Safe costs with well-prepared change order negotiations. Change orders are no longer a source of negative surprises. Transparent payment schedules and change order processes make sure project changes translate to comprehensible and fair budget revisions.
- ObjectivesA small biotech company is facing a change order from its CRO. The cost increase is a serious burden for the finances and in some aspects, the increased budget appears to be unjustified by the services planned. The client seeks support in reducing the change order.
- SolutionsThe PHARALL team reviewed the change order budget and the performance of the CRO to date. Then the project progress and the service performance were recalculated based on the original assumptions and a negotiation strategy was developed to reduce the costs.
- OutcomesThe change order was signed at a 20% reduced total amount saving the client a seven-figure amount of trial budget.
- PHARALL Alliance BenefitsAs a PHARALL Alliance member, you are always supported by a team of experts to make sure cost overruns in change orders are compared with project progress and budgets agreed. PHARALL makes sure you are only charged for the services that are agreed upfront.
- Testimonial"PHARALL negotiated and reduced unjustified CRO change orders which saved us a 7-figure amount representing 20% of the CRO budget. The investment in a collaboration with PHARALL pays off immediately and can be directly measured by realized cost savings through discounts and successful negotiations"
CFO of, BioPharma, Oncology Switzerland
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Rescue Trials Strategy & Execution
Clinical trials falling behind schedule benefit from our external view on your project challenges. We identify root causes of rescue situations, develop counter actions and execute rescue strategies.
- ObjectivesA small biotech company was unsatisfied with the trial performance in patient recruitment. The majority of sites declined to participate and recruitment rates were low in participating sites. The client experienced significant project delays and cost increases with no prospect of improvement.
- SolutionsTogether with the project teams, PHARALL facilitated a deep dive root cause analysis of the recruitment problem including analysis of site feedback and trial costs structure. The project teams then agreed to execute the developed turnaround plan.
- OutcomesRoot causes of low recruitment were identified and countermeasures were implemented. The project budgets were revised according to the new project plan and cost efficiencies were found in the new budget. The project is now on track to be completed as agreed.
- PHARALL Alliance BenefitsOur PHARALL Alliance Members benefit from preferred fees to a network of subject matter experts.
- TestimonialPHARALL has the right subject matter experts at hand to support your to reach the next inflection point
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CRO Management and Clinical Outsourcing Training
You need a strategy and operational support to keep oversight of your vendors. We develop the vendor governance and oversight SOPs taylored to your organisation and our project managers have the experince to get your trial back on track.
- ObjectivesA global pharma and biotech company has finished internal reorganizations and now needs to train its internal staff in vendor governance and clinical outsourcing. The objective is to train and align all stakeholders including clinical development, purchasing, legal and management.
- SolutionsPHARALL's has many years of experience in training biopharma companies to optimize their internal processes in clinical outsourcing. An interdisciplinary training agenda was setup and executed to cover all operational, financial and legal spects of clinical outsorcing.
- OutcomeOver 4 weeks and 4 different training sessions the client received an in-depth overview of the processes and best practices. In breakout sessions the client developed internal strategies to tackle the some of the important strategic questions.
- PHARALL Alliance BenefitsAs a PHARALL Alliance member, you are eligible to receive outsourcing and vendor governance trainings at a fraction of the costs.
- Testimonial"Very thorough course and informative." ... "Delivered with personality that kept everyone involved. He knew our roles/responsibilities." ... "Related relevant personnel experiences and how tools in the course were applied." ... "Presenter had good knowledge and examples for dealing with situations. The workshops were very engaging." ... "Clear presenter, slides clear and understandable."
- Clinical Outsourcing BootcampBook your Clinical Outsourcing Training here. Get it delivered virtually to your company as a tailored inhouse course.
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