FAQs

What is Real World Evidence?

Real World Evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real World Data (RWD). It provides insights into how a product performs in real-world settings, outside of controlled clinical trials, offering a comprehensive view of effectiveness and safety among diverse patient populations.

How can RWE solutions benefit pharmaceutical and biotechnology companies?
RWE solutions can aid these companies in understanding drug performance in real-life scenarios, which is crucial for product development, market access strategies, and post-market surveillance. It helps in identifying treatment gaps, enhancing patient outcomes, and supporting regulatory and reimbursement decisions.
What types of studies can be conducted using RWE?
A variety of studies can be conducted using RWE, including hypothesis testing, retrospective, prospective, cross-sectional, epidemiological, and pragmatic studies. These studies can fill evidence gaps left by randomized controlled trials and provide a broader understanding of medical products.
How does MCS ensure the quality and reliability of RWE studies?
MCS ensures quality and reliability by employing rigorous scientific methods, advanced data analytics, and ensuring compliance with regulatory standards. We use validated methodologies and robust data sources to provide accurate and actionable insights.
Can RWE be used for regulatory purposes?
Yes, RWE is increasingly being recognized by regulatory agencies for various purposes, including but not limited to, post-marketing surveillance, label expansions, and as supportive evidence in regulatory submissions.
How does MCS's RWE solutions integrate with digital transformation in healthcare?
MCS’s RWE solutions leverage digital transformation by utilizing advanced data analytics, machine learning, and artificial intelligence to process and analyze large sets of RWD, thus accelerating the delivery of healthcare insights and fostering innovation in patient care.
What is the role of patient-centric technology in RWE?
Patient-centric technology in RWE involves tools and platforms that engage patients and healthcare providers, enhancing the collection and analysis of patient-reported outcomes. This leads to a more comprehensive understanding of patient experiences and treatment outcomes.
How does MCS handle data privacy and compliance in RWE services?
MCS is committed to the highest standards of data privacy and compliance. We employ state-of-the-art data encryption and protection measures, adhering to all relevant regulations to ensure the security and confidentiality of patient data.
 What makes MCS's approach to RWE unique?
MCS’s approach to RWE is distinguished by our global coverage, diverse therapeutic expertise, and commitment to a patient-centric approach. We combine cutting-edge technology with a deep understanding of the healthcare landscape to deliver tailored RWE solutions.
How can I learn more about partnering with MCS for RWE solutions?
To learn more about partnering with MCS for RWE solutions, you can reach out to our experts by visiting our contact page or by scheduling a consultation to discuss your specific needs and how our RWE solutions can benefit your organization.
What is a Functional Service Provider?

Functional Service Provider is a specialized services designed to enhance the efficiency and effectiveness of clinical development. They offer a flexible mix of expertise, resource management, and technology to support various aspects of clinical trials and research. These services are offered to Sponsors from Pharma, Biotech, Biopharma and Clinical Research sector.

How does Maxis Clinical Sciences tailor its FSP solutions to client needs?
MCS tailors its FSP solutions by closely collaborating with clients to understand their specific project requirements. This allows us to provide a customized blend of staffing, technology, and operational workflows that integrate seamlessly with the client’s existing processes.
Can you explain the scalability of MCS's FSP solutions?
Our FSP solutions are scalable to match the evolving needs of your projects. Whether you’re looking to expand your team for a large-scale global trial or require specialized expertise for a niche study, our FSP models can adapt to your organization’s growth and changing objectives.
What types of FSP models does MCS offer?
MCS offers a range of FSP models, including Full-Service, Functional Outsourcing, Hybrid, and Customized Solutions. Each model is designed to meet different client needs, from comprehensive project management to targeted support for specific functions.
How does MCS ensure cost-effectiveness in its FSP delivery?
We achieve cost-effectiveness through streamlined processes that maximize resource efficiency and minimize waste. Our strategic planning and resource allocation are designed to deliver high-quality solutions while keeping your budget in check.
What kind of experience and expertise does MCS bring to FSP partnerships?
MCS brings over two decades of experience in the FSP domain, with a global team of over 3,000 dedicated professionals. Our expertise spans across various therapeutic areas and clinical development stages, ensuring that we bring deep industry knowledge to every partnership.
How does MCS integrate innovation into its FSP services?
Innovation is at the core of our FSP services. We continuously explore new technologies and methodologies to enhance clinical trial processes. Our functionally integrated solutions are designed to foster innovative approaches that can improve outcomes and efficiencies.
What makes MCS a trusted partner in global clinical development?
Our global reach, extensive industry experience, and robust team of professionals make us a trusted partner. We are committed to delivering exceptional solutions and building long-term relationships based on transparency, collaboration, and mutual trust.
Can MCS provide FSP services for international clinical trials?
Yes, MCS has a strong global presence and can provide FSP services for international clinical trials. Our teams are equipped to handle the complexities of multi-site and multi-country studies, ensuring consistent quality and regulatory compliance.
How can I learn more about partnering with MCS for FSP services?
To learn more about our FSP services and how we can support your clinical development needs, please reach out to us through our contact page. Our team is ready to provide you with detailed information and discuss how we can tailor our services for your success.
What specific therapeutic areas does MCS specialize in for FSP services?
MCS offers FSP services across a wide range of therapeutic areas. Our team has extensive experience in oncology, cardiology, neurology, infectious diseases, and more. We tailor our expertise to the unique challenges and requirements of each therapeutic area to ensure the highest quality support for your clinical trials.
How does MCS handle data management and analytics in FSP solutions?
MCS utilizes the latest eClinical systems and electronic data capture (EDC) technologies to ensure efficient data management. Our clinical analytics and biostatistics services provide comprehensive data analysis, ensuring that your clinical trial data is accurate, reliable, and ready for regulatory submission.
Does MCS provide support for regulatory affairs and compliance?
Yes, MCS offers regulatory affairs services to ensure that all aspects of your clinical development are compliant with the relevant local and international regulations. Our team stays up-to-date with the latest regulatory changes and provides strategic guidance to navigate the complex regulatory landscape.
Can MCS assist with patient recruitment and site monitoring for clinical trials?
Absolutely. MCS provides patient recruitment solutions and remote site monitoring services to enhance enrollment and ensure the integrity of trial data. Our risk-based monitoring strategies are designed to optimize the quality and efficiency of site monitoring activities.
How does MCS ensure the quality and integrity of clinical trial data?
MCS is committed to the highest standards of data quality and integrity. We offer data quality oversight services, study data conformance services, and clinical data integration and aggregation services to maintain the accuracy and reliability of your clinical trial data throughout its lifecycle.
What is Biometrics in Clinical Trials?

Biometrics in Clinical Trials encompass collection, analysis, and interpretation of data in clinical trials. They play a pivotal role in ensuring the quality, integrity, and accuracy of data. At Maxis Clinical Sciences, our comprehensive services include Clinical Data Management, Electronic Data Capture, Quality Control, Data Integration, Reporting, and more.

How does MCS ensure data integrity, quality, and conformance in Clinical Biometrics?
MCS emphasizes the importance of data quality oversight, data anonymization, and study data conformance services. Our expert teams utilize state-of-the-art eClinical systems and tools to ensure top-notch data quality, integrity, and conformance with regulatory and industry standards throughout the clinical trial lifecycle.
What differentiates MCS's Clinical Biometrics Services from competitors?
MCS boasts a rich portfolio of services that includes Medical Writing, CDISC Compliance, and Data Standardization. Our commitment to patient-centric technology enablement and expertise in real-world data analytics positions us as a leading provider in the industry.
Can MCS customize Clinical Biometrics Services based on specific trial needs?
Absolutely. MCS understands that each clinical trial is unique. We offer tailored solutions, including patient recruitment, remote site monitoring, risk-based monitoring, and more, to meet the specific needs of each project.
How does MCS handle data security and privacy in Clinical Biometrics?
MCS adheres to stringent data security protocols and ensures compliance with global regulatory standards. Our data anonymization services guarantee patient confidentiality while allowing for meaningful analysis.
Does MCS offer training and support for Clinical Biometrics tools and systems?
Yes, MCS provides comprehensive training for eClinical systems, Electronic Data Capture (EDC), and other biometric tools, ensuring teams are well-equipped to navigate and utilize these tools effectively.
How does MCS's expertise in Real-World Evidence complement its Clinical Biometrics Services?
Our proficiency in Real-World Evidence Solutions allows us to offer insights beyond traditional clinical trials. Integrating RWE with Clinical Biometrics provides a holistic view of patient experiences, outcomes, and treatment effectiveness.
How does MCS's Clinical Data Management service enhance trial efficiency?
MCS’s Clinical Data Management services oversee all aspects of trial data management, from collection to validation, cleaning, and analysis. With our dedicated team, we guarantee consistent and top-tier data quality, paving the way for precise trial results and efficient regulatory submissions.
Can MCS assist with Clinical Analytics, Biostatistics, and Statistical Programming?
Absolutely. MCS offers specialized Clinical Analytics services that transform raw trial data into actionable insights. Our Biostatistics services play a role in trial design, data analysis, and interpretation. Additionally, our team of experts proficient in statistical programming languages and tools provides accurate analyses and reports that align with trial objectives and industry best practices.
Are MCS's CDISC Services compliant with the latest industry standards?
Yes, MCS provides CDISC services to ensure clinical trial data adheres to standardized formats. Our team remains updated on CDISC standards, ensuring data compliance throughout each phase of the trial.
What is Digital Health?

Digital Health encompass a comprehensive range of technologies including mobile applications, wearable health devices, and smart drug delivery systems designed to enhance the healthcare experience. They facilitate a more informed, engaged patient involvement in their own care and provide healthcare providers with advanced tools for better patient management.

How does MCS ensure the security of its Digital Health Solutions?
MCS prioritizes security across all digital health solutions. IntelliThera, for instance, employs advanced user authentication, data encryption, rights management, and audit trails to protect patient data and ensure compliance with healthcare regulations.
Are MCS's Digital Health Solutions customizable for different therapeutic areas?
Yes, MCS’s Digital Health Solutions, including the IntelliThera Platform, offer modular components and algorithms that are adaptable across a variety of therapeutic domains, ensuring flexibility and customization to meet diverse healthcare needs.
What measures are taken by MCS to ensure the safety and performance of its digital solutions?
MCS’s digital solutions are rigorously tested for safety and performance. This includes continuous device monitoring, systematic management of device configurations, scalable architecture, and comprehensive diagnostic tools for system health assessments.
How does MCS handle the regulatory process for its Digital Health Solutions?
MCS has a proven track record in navigating the regulatory landscape, ensuring that all digital health solutions are compliant with the necessary regulations and standards for a smooth transition to market.
What support does MCS offer for market entry of Digital Health Solutions?
MCS provides extensive support for market entry, including compliance assurance, readiness for healthcare provider and patient use, and strategic market positioning.
How can I partner with MCS for Digital Health Solutions?
MCS is open to partnerships that advance patient care through digital health innovations. Interested parties are encouraged to reach out through our contact page to discuss potential collaborations and learn more about customizing our technology for their needs.
What is Strategic Consulting Services at MCS?
Strategic Consulting Services at MCS encompasses a comprehensive suite of advisory roles that guide pharmaceutical and life sciences companies through the entire lifecycle of clinical R&D. Our services are designed to offer strategic, data-driven guidance, integrating deep industry knowledge with digital innovation to optimize the journey from discovery to delivery.
How does MCS approach Strategic Advisory and Consulting Services?
Our approach is holistic and client-centric. We engage with our clients to understand their unique challenges and objectives, offering tailored solutions that encompass planning, design, conduct, regulatory compliance, commercialization, and leveraging digital technologies to enhance efficiency and effectiveness in clinical R&D.
Can MCS assist with clinical trial design and regulatory strategy?
Absolutely. MCS provides expert guidance in clinical development and design, ensuring that trial designs are not only compliant with regulatory requirements but also aligned with therapeutic goals. Our regulatory strategy services help navigate the complex regulatory landscape, ensuring proactive compliance and foresight.
What role does digital innovation play in MCS's Strategic Consulting Services?
Digital innovation is at the heart of our strategic consulting services. We harness the power of AI, eClinical systems, and data analytics to redefine clinical R&D processes, enhance decision-making, optimize trial efficiency, and accelerate development timelines.
How does MCS ensure the commercial success of a product?
MCS’s strategic consulting extends to commercialization insight, where we prepare strategies for successful market entry and patient access. This includes integrated market access, pricing, reimbursement, health economics, and communication strategies to demonstrate the value of your product.
What kind of experience does MCS have in Strategic Consulting Services?
MCS boasts a team of industry veterans and subject matter experts with extensive experience across the clinical development ecosystem. Our professionals are focused on delivering solutions that balance investor expectations, regulatory scrutiny, healthcare provider requirements, and patient outcomes.
What makes MCS different from other strategic consulting service providers?
MCS differentiates itself through a unified approach that seamlessly integrates clinical insight with market foresight, operational excellence, and digital integration. Our commitment to partnership and collaboration ensures that we work as an extension of your team, focused on your success.
How can I learn more about partnering with MCS for Strategic Consulting Services?
To explore how MCS can elevate your clinical R&D strategy, we invite you to connect with us. Our team is ready to discuss your specific needs and how our strategic consulting services can support your objectives. Contact us today to start the conversation.
What support does MCS offer for market entry of Digital Health Solutions?
MCS provides extensive support for market entry, including compliance assurance, readiness for healthcare provider and patient use, and strategic market positioning.
How can I partner with MCS for Digital Health Solutions?
MCS is open to partnerships that advance patient care through digital health innovations. Interested parties are encouraged to reach out through our contact page to discuss potential collaborations and learn more about customizing our technology for their needs.
What is External Control Arms or Synthetic Control Arms in Clinical Trials?

External Control Arms or Synthetic Control Arms are comparator groups in clinical trials that are created using real-world data (RWD) from sources such as electronic health records, claims databases, and disease registries. They serve as an alternative to traditional control groups in clinical studies, particularly when randomization to a control arm may be challenging or ethically questionable.

How are Synthetic Control Arms created?

The creation of SCAs typically involves several steps:

  1. Identifying and accessing relevant real-world data sources
  2. Curating and cleaning the data to ensure quality and completeness
  3. Selecting a patient cohort that matches the characteristics of the study population
  4. Applying statistical methods such as propensity score matching to ensure comparability
  5. Conducting rigorous analyses to validate the synthetic control arm
What types of real-world data are commonly used in creating Synthetic Control Arms?

Common sources of real-world data for SCAs include:

Electronic Health Records (EHRs)

Insurance claims databases

Disease-specific registries

National health databases

Patient-reported outcome measures

What are the potential advantages of using Synthetic Control Arms?

Some potential advantages of SCAs include:

Reducing the number of patients needed for the control group

Potentially shortening trial duration

Allowing more patients to receive the experimental treatment

Providing real-world context to clinical trial results

Enabling trials in rare diseases or emergency situations where control groups may be unfeasible

What are the main challenges in developing reliable Synthetic Control Arms?

Key challenges include:

Ensuring data quality and completeness in real-world data sources

Addressing potential biases in the data

Achieving appropriate matching between the synthetic and treatment arms

Handling missing data

Meeting regulatory requirements for acceptability of SCAs

How do regulatory agencies view the use of Synthetic Control Arms?

Regulatory agencies such as the FDA and EMA are increasingly open to the use of SCAs, particularly in certain situations like rare disease trials or where randomization is challenging. However, they require rigorous methodology, high-quality data, and thorough documentation. Agencies have issued guidance documents outlining their expectations for the use of real-world evidence in clinical trials, including as synthetic control arms.

Refer: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products

What statistical methods are commonly used in the development of Synthetic Control Arms?

Common statistical methods include:

Propensity score matching

Inverse probability of treatment weighting

Doubly robust estimation

Bayesian hierarchical modeling

Machine learning approaches for patient matching and outcome prediction

In what situations might Synthetic Control Arms be particularly useful?

SCAs may be particularly valuable in:

Rare disease trials where patient recruitment is challenging

Oncology trials, especially for aggressive cancers

Situations where randomization to a placebo or standard of care may be unethical

Studies of emergency interventions (e.g., pandemic situations)

Long-term safety studies

How is the validity of a Synthetic Control Arm assessed?

Validity assessment typically involves:

Comparing baseline characteristics between the SCA and the treatment arm

Conducting sensitivity analyses to test the robustness of results

Assessing the plausibility of outcomes in the SCA compared to historical data

Evaluating the completeness and quality of the underlying real-world data

Potentially validating the SCA approach using data from completed randomized controlled trials

What are some limitations of Synthetic Control Arms?

Important limitations to consider include:

Potential for unmeasured confounding factors

Challenges in accounting for differences in care patterns across different healthcare settings

Difficulty in blinding investigators to the nature of the control arm

Potential skepticism from some stakeholders about the reliability of non-randomized comparisons

Limitations in available real-world data for certain outcomes or patient populations

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