Introduction

Maintaining compliance and operational continuity is crucial in the fast-paced world of medical affairs, especially during transition periods. According to the Medical Affairs Professional Society, the pharmaceutical and MedTech industries are highly regulated, with stringent requirements to ensure legal, compliant, and ethical operations. Non-compliance can result in significant penalties, including fines, regulatory audits, and reputational damage.

This case study highlights how My Medical Department (MMD) effectively addressed a critical staffing gap, ensuring seamless support and compliance for a leading pharmaceutical company. MMD helped the company maintain high compliance standards and operational efficiency during a challenging transition period by providing expert-led, flexible support. For more detailed insights into the importance of compliance in medical affairs, you can refer to this comprehensive white paper

The Challenge

The sudden departure of a key staff member left a significant void in a vital therapy area, creating an urgent need for expertise in reviewing and approving both promotional and non-promotional materials. With recruitment efforts underway, the company required an interim solution to uphold compliance standards and ensure business continuity without the immediate pressure of hiring a replacement.

The Solution

MMD swiftly provided immediate, flexible support tailored to the company’s needs. Our expert team seamlessly integrated with the existing medical and marketing teams, ensuring uninterrupted operations. Key aspects of our solution included:

• Signatory Review: Conducting thorough reviews of promotional and non-promotional materials per industry guidelines.
• Collaborative Efficiency: Working closely with the internal team to maintain efficiency and compliance.
• Gradual Onboarding: Implementing a structured onboarding process ensures a smooth transition once the new hire is selected.

Key Results

MMD’s intervention allowed the company to focus on recruiting the right candidate while maintaining high compliance standards. The structured onboarding process facilitated a smooth handover to the incoming Senior Medical Manager.

“At My Medical Department, we understand the unique challenges pharmaceutical companies face during periods of transition. Our flexible, expert-led support ensures that critical staffing gaps are seamlessly bridged, maintaining high standards of compliance and operational efficiency. By partnering with us, companies can focus on their core objectives while we handle the complexities of medical affairs with precision and care.” – Kwesi Ackah, Global Director of Strategic Development.

Enhancing Operational Efficiency and Customer Satisfaction Through Innovative Support Solutions for a Biopharmaceutical company.

This case study highlights how our team helped a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines in oncology, cardiovascular, immunology, and fibrosis. Their clinical research and medical departments play a crucial role in driving the success of their clinical trials, particularly in complex oncology studies. The need for reliable, efficient, and flexible support for ongoing trials and studies has always been critical for this company. Their research teams often require assistance with clinical queries, data management, and protocol adherence. Given the complexity of their global operations and the wide-ranging expertise required, finding a trusted partner to provide consistent support across multiple functions has been essential.

The Challenge.

The company faced several challenges in managing a large-scale oncology trial, including:

• Handling Large Volumes of Data: The oncology trial required extensive data cleaning and oversight to ensure the accuracy of the results.
• Study Site Support: With multiple sites worldwide, our team gave constant support to address medical queries and protocol deviations.
• Cross-Timezone Coordination: With teams in the USA, Australia, and Europe, it was essential to maintain continuity and ensure that support was available at all hours.
• Maintaining Service Level Agreements (SLAs): Ensuring that all medical reviews, data cleaning tasks, and study support were completed within tight timelines and agreed-upon SLAs was crucial.

The Solution.

My Medical Department, a trusted partner of the biopharmaceutical company, stepped in to provide a range of comprehensive services across various aspects of clinical trial management:

• Medical and Clinical Research Scientist Support: The team provided continuous medical support, particularly in managing study site medical queries and overseeing clinical research activities. This assistance was crucial to maintain the integrity of the study.
• Data Cleaning and Study Management: The team handled large volumes of data cleaning, ensuring all study data met the highest standards. They also supported safety database reviews, protocol deviation reviews, and medical writing for trial documentation.
• Global Availability Across Multiple Timezones: With a presence spanning the USA, Australia, and Europe, the team ensured seamless 24/7 support, effectively covering all time zones and guaranteeing constant availability for urgent queries or data reviews.
• Efficient Project Management: The team provided study project management and contributed to the medical reviews within the Medical, Legal, and Regulatory (MLR) team. Their project management expertise helped ensure the trials stayed on track and met deadlines.

Key Results.

 The collaboration between My Medical Department and the biopharmaceutical company resulted in numerous favourable outcomes:

• Timely and Accurate Data Management: Data cleaning tasks were efficiently completed within the agreed-upon SLAs, ensuring the accuracy and reliability of the trial data.
• Enhanced Study Site Support: The team’s prompt response to study site queries and protocol deviation reviews helped to keep the oncology trial on track without delays.
• Global Coverage and 24/7 Support: The ability to work across multiple time zones ensured that any challenges were addressed in real time, reducing delays and maintaining study momentum.
• Dependability and Trust: The biopharmaceutical company has consistently relied on My Medical Department for support, citing the team’s dependability and professionalism as key factors in their ongoing collaboration.

Testimonial.

 “My Medical Department has been a vital partner for our company, consistently providing ongoing flexible medical and clinical research scientist support. Over the years, they have provided crucial assistance for study site medical queries, overall study lead clinical research scientist support for a large ongoing oncology trial, and comprehensive data cleaning across multiple trials. They have adeptly managed large volumes of data cleaning, ad-hoc study site support, safety database reviews, protocol deviation reviews, study project management, medical reviews within an MLR team, and medical writing, consistently completing their reviews within our agreed-upon service level agreements. Their ability to work across multiple time zones, spanning the USA, Australia, and Europe, has proven uniquely helpful for around-the-clock support. Their highly skilled and experienced team consistently make themselves available when required, demonstrating their dependability as a trusted partner.”

Thank you for reviewing our case study on providing seamless global support for a leading biopharmaceutical company. If you are eager to discover how our innovative support solutions can transform your organisation’s operational efficiency and customer satisfaction, we urge you to contact us immediately.

Don’t miss the opportunity to leverage our expertise and drive unparalleled success in the biopharmaceutical industry. We look forward to collaborating and making a significant impact together. Act now to secure your competitive edge!

Creating compelling Pharmaceutical Clinical Trial Slide Decks.

In today’s rapidly evolving, data-driven world, pharmaceutical companies must present complex information precisely and efficiently. One mid-sized pharmaceutical company contacted us seeking assistance in creating slide decks for their pivotal clinical trials. These slide decks were to be used by externally facing medical staff in a non-promotional manner.

The Challenge

Our client’s primary challenge was to transform complex data from their clinical trials into digestible, easily understood and appreciated presentations. The slide decks needed to:

• Be visually appealing
• Be easy to comprehend
• Reflect on the company strategy and positioning
• Remain consistent in external messaging

Our Solution

To address the challenges our client faced, we assembled an internal team of top-tier scientists led by an experienced medical professional. This team, with their extensive knowledge and experience, worked closely with the client’s team to define the project scope and key deliverables.

Detailed Analysis and Key Message Extraction

Together, we performed a detailed analysis of the pivotal clinical trial data. We specifically focused on identifying key differentiating messages and pieces of information that would resonate with external audiences.

Aligning Messages with Company Strategy

Once we identified the key messages, we worked to align them with the company’s strategy and positioning, ensuring consistent external messaging.

Presenting Information in an Engaging Format

Our team designed the slide decks logically, simply, and concisely, infusing them with compelling storytelling techniques to maintain the audience’s attention and keep them engaged.

Creating Supporting Scripts

Additionally, we produced scripts to accompany the slide decks as supplementary materials, ensuring that the externally facing medical staff were well-equipped to present the information effectively.

Results

Our collaboration with the mid-sized pharmaceutical company resulted in:

• A set of visually appealing slide deck assets that teams could use externally in a scientific manner
• Clear communication of key messages from the pivotal clinical trials
• Consistency in external messaging

Following the successful implementation of this project, the overall medical brand awareness for this pharmaceutical company substantially increased.

Here’s what their MSL Manager had to say:

“Thank you, MMD; after so many years of working on the product, I now fully understand the key concepts of our clinical trials.”

This case study highlights the importance of simplifying complex data for more effective communication while emphasising the power of effective collaboration in achieving success.

If you would like to learn more about how we support similar businesses in creating compelling Pharmaceutical Clinical Trial Slide Decks, please contact us here or reach out to our Global Director of Strategic Development, Kwesi.