Medical affairs for Clinical Trials
Differentiate value in the real world by anticipating, identifying and prioritizing the evidence needs of all your stakeholders.
Parexel’s integrated evidence solutions inform decision-making across the development lifecycle
As medical affairs teams navigate the ever-increasing demands of multiple stakeholders in a rapidly evolving landscape, we share a common mission – delivering life-changing medicines to patients who need them most. Our tailored solutions empower you to unlock the full potential of your product. We support leaders of medical affairs in clinical trials, and throughout the development lifecycle to:
- Stay current and compliant with emerging regulatory requirements
- Balance scientific integrity with commercial interests
- Generate and effectively communicate robust scientific evidence
- Build and nurture meaningful relationships with KOLs
- Amplify the patient voice to maximize impact
- Ensure successful launch through effective communication, product differentiation and positioning in a competitive landscape
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years of experience in delivering evidence and communicating value
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RWE projects in the past 5 years
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MSLs hired and deployed
Solutions for medical affairs
- Breadth of real-world evidence expertise and study delivery
- HEOR and market access consultancy and implementation
- Global medical, epidemiological and regulatory expertise
- Specialty services, including MSL deployment and medical info call center
- Medical communications for patients, payers and HCPs
- Patient insights, engagement and advocacy
Breadth of real-world evidence expertise and study delivery
Parexel’s Real World Research team develops strategies, identify and apply the right data sources that generate RWE throughout the product lifecycle to help differentiate your products, beginning at the earliest stages of development. We are committed to helping our medical affairs customers to meet the expectations of regulators, payers, physicians and patients and give you the competitive edge – through an integrated evidence strategy.
HEOR and market access consultancy and implementation
We deliver literature reviews, economic modeling, outcome measure assessments, global pricing and market access expertise, P&MA strategies, payer engagement, HTA submissions, local market access planning, evidence synthesis and meta-analysis, as well as value communication. Our goal is to generate evidence that informs decisions, optimizes value, and helps our medical affairs customers to articulate the value of their products to maximize their impact in the market.
Global medical, epidemiological and regulatory expertise
Our expertise spans all therapeutic areas and includes in-depth disease landscape analysis, strategies to optimize and expedite regulatory pathways, and strategic product and clinical development planning. Our team excels in protocol development and optimization, ensuring studies are scientifically rigorous and aligned with your objectives. With our expertise in engaging with health authorities and facilitating regulatory submissions, we ensure a smooth and efficient process. Leveraging our strong scientific leadership and deep knowledge of epidemiology, we provide valuable insights to inform your decision-making.
Specialty services, including MSL deployment and medical info call center
By establishing and augmenting medical affairs capabilities, The Medical Affairs Company (TMAC) delivers staffing solutions through global outsourcing, talent acquisition via executive search and compliant medical information with call center solutions, as well as medical writing and informatics and well as medical meeting coverage. With more than 20 years’ experience in medical affairs for clinical trials, and part of Parexel since 2017, TMAC plans, develops and executes cost-effective solutions for medical affairs leaders.
Medical communications for patients, payers and HCPs
We understand that a effective communication of a product’s clinical and real-world evidence can’t succeed without reliably established insights and alignment on strategic objectives. Our integrated experts support across the development lifecycle, providing a continuum of flexible, strategic support and expert implementation including: strategic communication planning, thought leader identification, education and training, full-service meetings and events, patient-focused communications solutions, publication planning and execution and field medical tools for scientific exchange.
Patient insights, engagement and advocacy
As our customers strive to increase the impact of the patient voice, Parexel provides a 360-degree patient-first portfolio to ensure that the patient is represented at every step, through insights, engagement and advocacy. At Parexel, we work With Heart™ to make protocols more compelling to sites and patients, engage more representative patient populations, include patient advocacy group experts as part of design and delivery teams, and create customizable engagement plans by country.
Frequently Asked Questions
Medical Affairs plays a crucial role in clinical trials by serving as a bridge between various stakeholders in the pharmaceutical industry. It provides scientific expertise to support trial design and execution, engages with key opinion leaders, and offers medical information to healthcare professionals. The team also works closely with patient advocacy groups to ensure trials are patient focused.
In the regulatory sphere, Medical Affairs assists with submissions, participates in meetings with authorities, and supports publication planning to communicate trial results effectively. They develop educational programs for healthcare professionals and collaborate across different departments to align clinical trial objectives with overall product strategy.
Post-marketing, Medical Affairs continues to play a vital role in supporting additional trials and generating real-world evidence. Throughout all stages, they ensure compliance with regulatory requirements and ethical guidelines, maintaining scientific integrity in all communications. Their work is essential in validating the scientific and medical aspects of clinical trials and supporting the lifecycle management of pharmaceutical products.
Medical Affairs teams serve as a critical link between pharmaceutical/biotechnology companies and the scientific and medical communities. They are responsible for communicating complex scientific information about drugs and treatments to healthcare professionals, researchers, and other stakeholders. This involves presenting data at conferences, organizing educational programs, and managing relationships with key opinion leaders in relevant medical fields.
These teams also play a vital role in supporting clinical research by providing input on trial design and collaborating with academic researchers. They respond to medical inquiries, contribute to drug safety monitoring, and oversee the development of scientific publications. Additionally, Medical Affairs professionals offer crucial support for regulatory submissions and market access initiatives.
Internally, Medical Affairs teams act as scientific consultants, providing expertise to various departments within their companies. They ensure that products are used effectively and safely, and that the scientific community and healthcare professionals have access to accurate, current information about these products and their therapeutic areas. This multifaceted role makes Medical Affairs an essential component in the pharmaceutical and biotechnology industries.
The primary goal of Medical Affairs is to serve as a trusted scientific partner to healthcare professionals, researchers, and internal stakeholders. By providing accurate, unbiased, and up-to-date medical information, Medical Affairs teams aim to enhance the understanding of diseases, treatments, and pharmaceutical products. This goal supports better patient care and fosters credibility for the company within the medical community.
Another key objective of Medical Affairs is to gather and disseminate valuable insights that drive innovation and inform strategic decision-making. By engaging with key opinion leaders, participating in scientific conferences, and supporting clinical research, Medical Affairs teams collect crucial feedback and data. This information helps shape future research directions, product development, and medical strategies within the company.
Lastly, Medical Affairs aims to ensure the safe and effective use of pharmaceutical products. This involves supporting pharmacovigilance efforts, contributing to regulatory compliance, and educating healthcare professionals on proper product use. By focusing on these areas, Medical Affairs teams play a vital role in optimizing patient outcomes and maintaining the company's commitment to public health and safety.
Medical Affairs plays a crucial role in clinical trials within the pharmaceutical industry for several important reasons:
- Scientific Expertise: Medical Affairs teams provide valuable scientific and medical expertise throughout the clinical trial process. They contribute to protocol design, help interpret complex data, and ensure that trials are scientifically sound and clinically relevant. This expertise is essential for developing effective and safe pharmaceutical products.
- Stakeholder Engagement: Medical Affairs professionals act as a bridge between the company and external stakeholders, including investigators, key opinion leaders, and regulatory bodies. They facilitate communication, gather insights, and build relationships that are critical for successful trial recruitment, execution, and eventual product adoption.
- Ethical and Regulatory Compliance: Medical Affairs ensures that clinical trials adhere to ethical standards and regulatory requirements. They help maintain the integrity of the research process, ensuring that patient safety and data quality are prioritized throughout the trial.
By fulfilling these roles, Medical Affairs contributes significantly to the success of clinical trials, which are fundamental to bringing new, safe, and effective treatments to patients. Their involvement helps pharmaceutical companies navigate the complex landscape of drug development, ultimately supporting the industry's goal of improving public health through innovative therapies.