SOLUTIONS
Medatrek is optimizing the way the biopharmaceutical companies manage outsourced clinical trials, to help achieve the full potential of outsourcing activities throughout the drug development journey.
We offer consulting services that help clients optimize the strategies and management in clinical outsourcing programs. Our trusted experts, spanning the full spectrum of drug development and clinical outsourcing, bring deep insights to clients to enable effective decision-making and efficient implementation in outsourced clinical programs.
We understand every client has unique goals in the clinical programs. Our management solutions for execution, which are purpose-built for your products and requirements, allow you to stay focus on the core competence in business development while ensuring compliance and eliminating operational bottlenecks.
We believe our consulting and management services can be beneficial to clients in following aspects:
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Enhance efficiency and revenue in the entire biopharmaceutical development cycle
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Facilitate informed go/no-go decisions
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Improve operational performance
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Streamline communication among sponsors and CROs
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Drive CRO performance and quality
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Ensure risk identification and mitigation
Select your objective to learn more:
Phone Consultations
1-on-1 phone conversations with clinical research experts
Meetings
Face-to-face, private meetings with clinical research experts
Engage with us
On-site Visits
On-site visits, reviews and assessments by clinical research experts
Strategic Projects
Outsourced clinical projects executed by independent experts
Board Placements
Experts placed into longer-term advisory, operational or management roles
Our short to long term services include
Optimize your clinical outsourcing approach
The breadth of clinical outsourcing experience to guide you toward success in drug development
To select a suitable outsourcing model, streamline the collaboration and enhance the efficiency of oversight, you need a series of strategic advice and insights to connect the planning and execution stage of your clinical outsourcing programs.
Medatrek can help. Because our team has over 20 years of experience involved in clinical development and operations with biopharmaceutical companies as well as CROs. We have helped develop a number of marketed drugs worldwide through the clinical outsourcing models. Here are a few areas we can guide you to optimize your clinical outsourcing approach.
CRO Identification and Evaluation
CRO selection is a critical process in clinical outsourcing that can be challenging to many sponsors, particularly for small to medium-sized biopharmaceutical companies. Having worked closely with sponsors and CROs for over 20 years in the Asia Pacific regions, our team offers independent, systematic evaluation of clinical service providers to help clients make informed decision of choosing suitable vendors that best fit the project goals, timeline and budget.
CRO Identification and Evaluation
Clinical Technologies Adoption
While sponsors are utilizing various clinical technologies to accelerate clinical trials, choosing fit-to-purpose tools/systems has become significantly important for the success of the project delivery. Our team has hands-on experiences of using commercially available clinical systems, so we can provide objective advice to our clients for selecting suitable technologies that meet the study-specific requirements.
Clinical Technologies Adoption
CRO Oversight Plan Development
Proper CRO oversight is essential for achieving successful project deliveries, therefore, developing clearly defined quality metrics and allocating sufficient resources to oversee CRO performance are the top priorities to drive quality and efficiency in clinical trials. Medatrek performs comprehensive analysis in clinical outsourcing practices to give advice to sponsors for quality management and effective oversight in outsourced clinical trials.
CRO Oversight Plan Development
Outsourcing Relationship Assessment
We conduct clinical outsourcing relationship assessments that help both sponsors and their partners come to mutual understandings of study expectations. These also streamline communications of all parties, so that they can proactively address study issues and share key information among stakeholders throughout clinical trials, strengthening long-term collaborative relationships.
Outsourcing Relationship Assessment
Customized Services
We can also provide customized consulting services to help sponsors make more informed business decisions and drive project efficiency. Our team works with stakeholders to identify the operational bottlenecks and develop strategic execution plans to mitigate the risks throughout the clinical research process.
Customized Services
Get Started with Medatrek
Resource your clinical outsourcing capabilities
New Generation Clinical Outsourcing Management Models for Execution
Are we selecting a right CRO for my clinical outsourcing program? How can we ensure getting optimal deliverables from the outsourced services? How do we effectively assess the service provider’s performance throughout the outsourced clinical program? What issues should we escalate? These are the questions sponsors commonly ask themselves many times.
Medatrek offers better and faster new generation clinical outsourcing management services to support sponsors from planning, launch, management through closure of the clinical programs. We can tailor our services and solutions that you need for your trial to succeed.
RFx and Bid Defense Management
Writing a successful Request For Information (RFI) and Request For Proposal (RFP) is the key for sponsors to achieve timely project deliverables and good collaborative relationships. We engage with sponsors from RFI/RFP to bid defense, to determine the outsourcing strategies, study-specific requirements and budget expectation. We customize the RFx documents on behalf of sponsors in order to obtain realistic project proposals and accurate study budgets from the potential CRO candidates during the CRO selection process.
RFx and Bid Defense Management
Contract and Budget Management
We provide independent review and advice of the initial study contract and budget before project award, to help sponsors obtain realistic forecasts of study timelines (e.g., start-up, recruitment, close-out), scope of work and study budget. We also foster transparent communications between stakeholders from study kick-off through study closure by developing key performance indicators (KPIs) to ensure all parties are aware of study expectations and potential issues such as unforeseeable change orders.
Contract and Budget Management
Study Plans Review and Optimization
When CROs provide sponsors with a number of study-specific management plans at kick-off meetings, it always require sponsors to put in intensive efforts to review and finalize the plans. However, even after such lengthy reviewing process, the reliability and efficiency of the plans may still remain uncertain. We can provide sponsors with professional resources to optimize these plans, and in turn achieving study expectations and maximizing the outsourcing value.
Study Plans Review and Optimization
CRO Performance Oversight
We offer comprehensive routine tracking and analysis of project quality metrics and CRO performance indicators to evaluate the CRO performance from study startup through management and deliverables. These measurements allow sponsors to determine if their vendors are outperforming or underperforming in certain aspects and take proactive actions to rectify the underlying issues.
CRO Performance Oversight
Risk Identification and Mitigation
We support sponsors implementing the ICH E6 (R2) guidelines within their organizations or across partnerships by optimizing study guidelines, tools and processes, executing routine risk reviews, and leading proactive approaches to identify, evaluate, escalate and mitigate the risks in the clinical trials.
Risk Identification and Mitigation
CAPA Overview
On behalf of our sponsors, we work closely with the third party vendors to oversee the quality issue resolution process independently to ensure the identified quality issues are addressed promptly and properly, so that sponsors can confirm they are in control of the scope of quality impact and the quality management process.
CAPA Overview
Case Study Sharing and Training
We continuously share our hands-on experience with our sponsors in clinical outsourcing, operations and management from ideation through planning and execution in the effective training sessions. Along the way, sponsors will be able to improve decision-making across clinical processes and to advance the quality, speed and cost-effectiveness of the clinical outsourcing programs.