ABOUT
Sheilah Johnson-Rocha MSc., MAPM
Professional Bio
Founder
As a recognized thought leader in clinical development operations and project management with over 20 years of experience, I excel in navigating the intricate clinical trial ecosystem. Expertise in cell and gene therapy has driven my success in leading the development of independent business units. In my role as a Business Unit Leader, I have spearheaded organizational strategy, developed processes and SOPs, integrated cross-functional processes, and managed Operational and Program Managers.
As a patient-centric leader and strategist, I ambitiously build high-performing, cohesive teams to ensure early, high-quality program execution. My deep immersion in clinical development includes leading from concept, contributing to formulation, early strategic development during the concept phase, protocol development (IND submissions and responses), CDA, feasibility assessments, informed consents, contract and budget negotiations, NDAs, CSRs, and developing lay summaries.
As a subject matter expert in Oncology, Hematology, CGT, Autologous, Allogeneic, Rare Disease, and Pediatric Rare Disease, I bring a wealth of knowledge and experience that allows me to pivot, adapt, and innovate. This expertise ensures the successful delivery of early-phase, novel programs, evidenced by the successful enrollment of four pediatric patients identified globally for a rare gene program. Additionally, I hold certifications in Artificial Intelligence and Digital Technologies and have successfully deployed AI-enabled, integrated forecasting applications and portfolio analytics platforms at the enterprise level.
My passion for driving innovation in life sciences is reflected in my keen interest in emerging therapies, personalized medicine, and the integration of cutting-edge technologies into clinical trial design. Staying abreast of industry advancements, I continuously leverage innovations to deliver breakthrough treatments to patients.
Master of Science, Management and Healthcare Administration: GPA 3.83
PMI; Generative AI for Project Management
PMI Data Landscape for Gen AI in PM
Digital Research
National Library of Medicine:
Region 3; NNLM ID: 96075
Project Management, PMI Kick Off:
Certificate no. 5064855
PMI: Predictive Project Management
Association for Project Management
License No. P030298
Leading the Way in Clinical Research Services
Welcome to Critical Path Clinical, your trusted partner in delivering innovative and high-quality clinical research services to pharmaceutical, biotechnology, and medical device companies across the globe. Since our inception, our mission has been clear: to guide our clients through the complex and ever-evolving landscape of clinical trials, ensuring that life-saving therapies reach the market both efficiently and effectively.
Expertise That Drives Success
Our team at Critical Path Clinical is composed of seasoned professionals with diverse backgrounds in clinical research, regulatory affairs, and project management. This wealth of experience allows us to collaborate closely with our clients, developing customized solutions tailored to their unique needs and goals. Our commitment to delivering quality results on time and within budget sets us apart, as we consistently strive to exceed expectations in every project we undertake.
Innovation and Continuous Improvement
In the fast-paced field of clinical research, staying ahead of the curve is essential. At Critical Path Clinical, we place a strong emphasis on innovation and continuous improvement. Our team remains at the forefront of industry trends, regulations, and technologies, enabling us to offer cutting-edge solutions to our clients. Whether you're a small start-up or a multinational corporation, we have the expertise and resources to support your clinical development needs.
Unwavering Commitment to Quality and Compliance
Quality and compliance are the cornerstones of our work at Critical Path Clinical. We adhere to stringent regulatory standards and industry best practices to ensure that all our services meet the highest levels of quality and integrity. Our team is dedicated to maintaining the highest ethical standards in all aspects of our work, with a strong focus on transparency, communication, and accountability.
Comprehensive Suite of Services
Our comprehensive range of services includes:
Clinical Trial Management: Efficiently managing trials across various therapeutic areas.
Regulatory Affairs: Navigating the complexities of regulatory submissions and approvals.
Data Management: Ensuring accurate and secure handling of clinical data.
Biostatistics: Providing robust statistical analysis to support clinical findings.
Medical Writing: Crafting clear and precise documentation for regulatory submissions and publications.
We have successfully managed a wide array of clinical trials, including those in oncology, neurology, cardiology, and rare diseases. Our expertise spans all phases of clinical development, from initial planning and regulatory submissions to data analysis and final reporting.
Passion for Making a Difference
At Critical Path Clinical, our passion lies in making a meaningful impact on the lives of patients worldwide. Partnering with us means entrusting your clinical research program to experienced professionals dedicated to helping you achieve your goals. We are committed to accelerating your clinical development program and bringing innovative therapies to market faster.
Get in Touch
Are you ready to revolutionize your clinical research program? Contact Critical Path Clinical today to discover how we can support your journey and help you bring life-saving therapies to market with unmatched efficiency and effectiveness.
By choosing Critical Path Clinical, you're opting for a partner that combines expertise, innovation, and a commitment to quality, ensuring your clinical research program's success every step of the way.
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戦略的イノベーション: 成功する戦略とソリューションを開発し、実装した実績。
最先端のソリューション: ライフサイエンス分野向けにカスタマイズされた AI とデジタル ツールに関する専門知識。
品質への取り組み: 運用および品質管理において最高水準を維持することに尽力します。