Whether you are a start-up with a burn-rated budget or an emerging/established company, we charter the strategy and execute the plan that`s right for your needs.
No more wasted time on coping and keeping up. Get the help you need, when you need it.
Find the right team to take your clinical project forward without wasting time, energy and money.
Contact Autumn Lang at +49 174 928 6564 for a free consultation.
Strategy development, Plan development, and Review
Clinical project management, Project planning and documentation, Resource coordination, issues resolution and rescue
Experts in Regulatory Affairs & Quality Assurance, Market Access: Commercialization & Reimbursement, Biostatistics, Data management, Data programming, Medical writing, KOLs, etc.
Clinical research function processes captured & maintained in QMS, clinical project auditing, training
For a free consultation
We take the time to meet and listen to you. Evaluating together your project details and needs, we prepare an experienced-based proposal with tasks, deliverables and costs that you understand the first time. Our open and transparent approach allows us to offer you the best pricing up front as well as plan for the unanticipated challenges to come.
Value and recognizes even the smallest clinical project may make a major contribution to selling a better quality of life. Specialty is chartering the clinical regulatory commercialization strategy for innovative medical devices. Global compliance achievement of 19 years in diverse clinical regulatory roles in the medical device industry and CROs.
Clinical research professional with 12 years of experience within highly regulated and innovative medical device industry, including experience with pediatric populations.
Strong understanding of specific needs for start-up companies, with interdisciplinary collaborations with experts from different backgrounds.
Clinical Quality professional with 13 years of experience within the pharmaceutical, medical device and clinical research industries.
Designed and implemented innovative QM systems and managed aspects of quality for drug and medical device studies from quality-by-design phase through clinical studies and inspections resulting in regulatory approval.