Medical Affairs Solutions

At TIVMEK, we help organizations build and execute high-impact medical affairs strategies that bridge science and clinical practice. Our team supports MSL outsourcing, KOL mapping and engagement, advisory board planning, scientific communication, and medical education initiatives to strengthen credibility and market readiness. With deep therapeutic expertise and strong stakeholder connectivity, we ensure that medical insights drive strategy from pre-launch through post-marketing success.

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Enhancing clinical trials

Clinical trials are a cornerstone of the product life cycle, providing essential evidence from early development through to post-launch.

TIVMEK medical affairs experts can enhance clinical trials in several ways:

Protocol Development: Design robust trial protocols that meet regulatory requirements while addressing scientific questions.
Site Selection and Monitoring: Identifying the right clinical sites and investigators can improve patient recruitment and retention.
Patient Engagement: Engaging patients early in the trial design process can lead to better outcomes and higher satisfaction.
Data Management: Ensuring that data is collected, analyzed, and reported accurately is crucial for trial success.

By leveraging expert insights, companies can optimize their clinical trials, leading to faster results and a more efficient pipeline.

Building Partnerships with KOLs

Key opinion leaders (KOLs) are influential figures in the medical community. They can provide valuable insights and support for pharmaceutical products.

TIVMEK medical affairs experts can accelerate KOL connectivity through:

Sharing network: Leverage existing partnerships with key centers and KOLs to accelerate critical launch activities and advocacy.
Engagement Programs: Develop programs that facilitate ongoing communication and collaboration with KOLs.
Advisory Boards: Establish advisory boards to gather feedback on product development and market strategies.
Educational Initiatives: Offer educational opportunities that align with KOL interests and expertise.

By fostering these relationships, companies can gain critical insights that inform their strategies and enhance their credibility in the market.

Leveraging Real-World Evidence

Real-world evidence (RWE) is becoming increasingly important in the industry. It refers to data collected outside of traditional clinical trials, providing insights into how products perform in everyday settings.

TIVMEK medical affairs experts can help pharmaceutical companies leverage RWE in several ways:

Data Collection: Developing strategies for collecting RWE from various sources, such as Investigator-Initiated Research (IIR), electronic health records and patient registries.
Analysis and Interpretation: Analyzing RWE to support product claims and inform decision-making.
Communication: Effectively communicating RWE findings to stakeholders to enhance product credibility.

By incorporating RWE into their strategies, companies can strengthen their value propositions and improve patient outcomes.

Navigating Regulatory Challenges

Regulatory challenges can pose significant hurdles for companies. Understanding the regulatory landscape and ensuring compliance is crucial for success.

TIVMEK medical affairs experts can assist in navigating these challenges by:

Regulatory Strategy Development: Creating comprehensive regulatory strategies that align with product development timelines.
Submission Preparation: Assisting in the preparation of regulatory submissions, including clinical trial applications and marketing authorizations.
KOL input and presentations: Integrating expert insights into regulatory strategies and leveraging KOL support in presentations to health authorities

By addressing regulatory challenges proactively, companies can reduce delays and accelerate their launches.

Scientific Evaluation of Licensing Candidates

More than ever, medical affairs is working hand-in-hand with business development teams—particularly during the due diligence phase—to ensure that in-licensing candidates meet critical success factors. These include addressing an important unmet medical need, demonstrating strong clinical value, defining a clear place in therapy, and navigating the competitive landscape.

TIVMEK medical affairs experts can help pharmaceutical companies by:

Evaluating clinical data: Identifying evidence gaps and developing strategies to align with regulatory authority expectations.
Assessing unmet medical needs: Ensuring the product addresses a significant clinical gap while delivering strong value to patients and healthcare systems.
Engaging KOLs: Organizing expert consultations to validate the therapeutic positioning and confirm the true clinical need.
Supporting product launches: Helping partners bring products to market directly or optimizing out-licensing opportunities.

Medical Information

Responding effectively to medical information requests (MIRs) from healthcare professionals is a core function of Medical Affairs that builds trust and supports the safe, appropriate use of therapies.

TIVMEK medical affairs experts can help companies manage MIRs with efficiency, accuracy, and compliance:

Process Development: Establishing standardized, compliant procedures and response templates for handling unsolicited requests.
Scientific Accuracy: Ensuring responses are evidence-based, balanced, and aligned with the latest clinical data.
Knowledge Integration: Leveraging insights from MIRs to identify knowledge gaps, inform educational initiatives, and guide future evidence generation.

By optimizing how medical information requests are managed, companies can strengthen relationships with clinicians, enhance transparency, and ultimately improve patient care.

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Montreal, QC

Canada