TAILORED MEDICAL WRITING SOLUTIONS FOR DRAFTING CLINICAL OVERVIEW IN COMBINATION THERAPY
Category: A Product targeting type 2 Diabetes
Geography: N/A
Product Type: Drug
Therapeutic Area: CTD Module
Background/Client Requirement:
The client is an India-based pharmaceutical company that manufactures a wide range of drugs across various therapeutics areas. With a strong market presence, the company is deeply committed to upholding ethical standards and moral values in all its business operations. The client outsourced Techsol for drafting clinical overview (Module 2.5) for a Type 2 anti-diabetic drug, ensuring alignment with international regulatory requirements. ensuring alignment with international regulatory requirements.
Project Aim:
The aim of the project was to develop a comprehensive, regulatory-compliant clinical overview for Type 2 anti-diabetic drug to support the client’s submission to international regulatory authorities. The clinical overview needed to be effectively demonstrate the drug’s efficacy, safety, and therapeutic benefits while aligning with the client’s commitment to ethical standards and regulatory requirements, ultimately facilitating a streamlined and successful approval process.
Techsol Approach:
Techsol adopted structured and evidence-based apprach to understand the client’s regulatory, clinical, and ethical needs, including an in-depth review of the anti-diabetic drug’s therapeutic profile, highlighing the need for the efficacy, safety and pharmacological data. A comprehensive literature review was conducted, focusing on Type 2 diabetes management and current treatment trends. Using structured templates in line with ICH guidelines, the team drafted the clinical overview, incorporating detailed sections on pharmacology, clinical efficacy, and safety. Techsol’s internal quality assurance (QA) processes ensured each draft adhered to regulatory standards. Regular checkpoints were scheduled to review progress with the client, resulting a robast clinical overview.
Challenges:
Drafting a clinical overview for a combination of drugs of Type 2 anti-diabetics in the Common Technical Document (CTD) Module 2.5 involves several significant challenges.
- Complexity of Data: Integrating the data from multiple sources, including clinical studies and real-world evidence, presented a challenge in maintaining a cohesive narrative on efficacy and safety.
- Regulatory Compliance: As the drug was intended for international markets, it was essential to meet diverse regulatory requirements was challenging, particularly those of the US FDA, EMA, and CDSCO. Ensuring compliance across these regions required meticulous attention to guideline details.
- Time Constraints: The project was on a tight timeline, given the client’s planned submission schedule.
- Structured Drafting Approach: A structured approach was adopted, segmenting the clinical overview into sections (e.g., efficacy, safety, pharmacokinetics) to facilitate concurrent drafting and review. This allowed the team to expedite the process without compromising with content quality.
- Cross-Functional Team Collaboration: Techsol expert clinical pharmacologists, regulatory writers, and quality assurance teams along with medical writing teams enabled efficient data handling, compliance adherence, and expedited reviews.
- Data Curation: Techsol medical writing teams utilized existing clinical data from monotherapy trials of each drug to support the combination’s profile. Incorporated meta-analyses of published studies and real-world evidence to supplement clinical trial data. This reduced the duplicate studies and expediated the regulatory process.
- Document Management Tools: Techsol has adopted to the client’s document management tools, enabling real-time document sharing with the client and version control to track changes. This also enhanced data security and streamlined feedback integration.
- Dedicated Project Management: A dedicated project manager ensured that timelines were adhered to and served as the primary liaison between the client and Techsol’s team.
- Regulatory Intelligence: Conducted comprehensive regulatory intelligence, ensured to understand the specific requirements and guidelines of target markets. This includes monitoring regulatory changes and trends.
Project Achievements:
Techsol successfully delivered a high-quality clinical overview within the client’s tight deadline, cloud met their submission requirements on time. The document was meticulously crafted to comply with the regulatory standards, aligning the client’s submission with international guidelines. The client expressed satisfaction with the quality, professionalism, and thoroughness of the clinical overview, recognizing Techsol’s expertise in regulatory document preparation.
By implementing these solutions, the client was able to navigate the complexities in drafting a clinical overview for combination therapies more effectively, ensuring thorough documentation of safety and efficacy while meeting diverse regulatory requirements. This successful project outcome not only fulfilled the client’s immediate needs but also reinforced a strong client-consultant relationship, paving the way for future collaborations.
Our Medical Writing Capabilities:
- We ensure regulatory compliance, delivering high-quality content that instills confidence in our clients’- medical communication endeavors.
- Our team of medical writing experts comprehensive knowledge across various therapeutic areas, ensure precise and accurate communication designed to specific healthcare needs.
- Our expertise and Impeccable domain knowledge ensure accuracy, credibility, and professionalism.