High-quality global clinical project management
Expert operational and management solutions for drugs, diagnostic agents, and medical devices development projects
Fit-for-purpose. Focused. Quality Excellence.
Your clinical trial executed in the easiest and most expeditious way, within higher quality and compliance standards
Vortex Pharma Solution provides in-depth clinical operations expertise covering trial life cycle end-to-end process. Using a holistic system, we ensure that your clinical trial is designed, setup, conducted, and reported with a risk-based approach, reasonable costs and the shortest possible timelines. We offer fit-for-purpose solutions to meet your specific needs and get your trial executed as planned.
Services offered
We are a specialized life science consulting company focused on conducting and supporting clinical projects management, advancing clinical trials and getting development projects back on track.
Global Clinical Project & Trial Management
- Trial start-up with a Quality by Design (QbD) approach, submission/approval regulatory process, enrolment & recruitment strategy
- Trial execution, retention & boosting action plan, database lock, closure and reporting
- Budget, contracting, and finance setup
- Clinical Product Development Support and Counselling
Decentralised Clinical Trials
- Use of decentralised clinical trial elements
- Implementation of digital health technologies
- Direct-from-patient lab sampling
- Fit-for-purpose design
- Hybrid or full approach
Trial Site Management
- Support to site processes, e.g., handling of patient payment and reimbursement (concerning travelling, accommodation, meals), drug accountability, trial participants scheduling, trial site master filing, recruitment and retention site strategy and initiatives
Clinical Trial Outsourcing
- All models, (functional service providers, full-service and hybrid bespoke)
- Vendor Selection and Management
- Risk-Based Sponsor Oversight
Clinical Trial Supply Management
- Setup & update of IRT systems specifications, labelling review and approval, handling and oversight of supply processes e.g., ordering, shipment, import process, local depot, distribution to sites, return of supplies for destruction
- Direct-to-Patient setup
Clinical Quality Assurance and Compliance
- Risk-Based Quality Management Plan
- Audit and inspection readiness
- Proactive risk-based audit and inspection oversight
Regulatory Science related to Clinical Trial Applications (CTAs)
- Support with clinical submission of packages for initial CTAs
- Assistance with amendment of CTAs
- Support answering questions during agencies & Ethics Committee/IRB assessment period
Patient Engagement
- Ensure your organisation fully understands your patients’ journey
- Strategy at program and study levels
- Ensure your project follows the FDA Patient-Focused Drug Development (PFDD) approach
- Coach your team how to better listen to your patients’ voice
Training & Coaching
- Training on ICH guidelines with an emphasis on E6 and E8 revisions, EMA, FDA and MHRA guidelines and regulations
- Mentoring
- Risk-Based Quality Management
Therapeutic areas
- Rare and ultra-rare diseases (orphan drug designation)
- Endocrinology/metabolic diseases (diabetes, obesity, achondroplasia, growth hormone deficiency, hypoparathyroidism, thyroid-related diseases)
- Hepatology (focal liver lesions, non-alcoholic steatohepatitis [NASH])
- Nephrology (chronic kidney disease [CKD])
- Neurology (Alzheimer’s disease)
- Gastroenterology (Crohn’s disease)
- Rheumatology (Rheumatoid Arthritis)
- Haematology (haemophilia, trauma, extensive surgery, intracerebral haemorrhage)
- Cardiovascular (CV outcomes, arterial hypertension)
- Oncology (breast cancer)
- Dermatology (hyperhidrosis)
Trial populations
- Paediatrics
- Elderly
- Adults
Products investigated
- Drugs/medicines
- Diagnostic agents
- Medical devices
Vortex Pharma Solution is owned and managed by an experienced project manager who has been driving clinical trials phases II-IV in various therapeutic areas, including rare diseases and special populations since 2000.
Flavia successfully led development projects of drugs, diagnostic agents and medical devices for biotech and pharma companies in a global scale.
Flavia Christina Ladwig Robles, BSc.Pharm.
Principal
Passionate about bringing out the greatness in people, Flavia leads by empowering her study team to build and execute their best projects. Within Vortex Pharma Solution framework and agility, Flavia aims to make a bigger impact on the product development business of her clients by simultaneously simplifying tasks and accelerating results.
What our customers say
Client References
Reliable, risk-based and purposeful processes, providing fast and tangible results
Manolo Ernesto Beelke
Medical Lead Consultant – Ascelia Pharma AB (Germany)
I worked with Flavia at a pivotal phase III clinical trial from Ascelia. She joint the team at a critical moment, when we tried to reignite recruitment. From the first day, she brought her passion with verve into the discussion and contributed significantly during the solution finding process. She is very experienced within clinical operations and understands doing triage of tasks to prioritize. She has this unique mixture of cultures, which you gain only when you grow up in Brazil and relocates as a young person to Denmark. This cultural cocktail has an important impact on her mindset and the way how she face challenges, the mental flexibility to find unique tailored solutions and the discipline and tenacity to not give up till the goal has been achieved.
In addition, due to her very broad experience she has accumulated overtime, she always can find the solution most tailored to the client's real need. She does not need to rely on very few options, but can take advantage from her cornucopia of knowledge, experiences and skills. I recommend her for anyone who requires a new refreshing input, when the old established methods must be rethought. Maybe you will discover the unimaginable.
Milva Monova
Milva Monova Associate Director, Project Delivery – ICON plc (Bulgaria)
I had the pleasure to work with Flavia on a challenging clinical study where she brought delivery leadership experience and contributed to a successful outcome. I am impressed that Flavia thrives on challenges and embraces change as an opportunity to innovate. What I value the most is her great communication style and that she is flexible in managing changing priorities for successful delivery. Flavia is very experienced in working with people across cultures, recognizing the differences and managing to lead a team towards better outcomes. I wholeheartedly recommend Flavia as she is always making a difference that projects and teams can only benefit from.
Eve Kwan, RQAP-GCP
Vice President, Quality Assurance – Crinetics Pharmaceuticals (United States)
I had the pleasure of getting to know Flavia at Ascendis Pharma while she was working in the clinical study team. My role was to oversee Health Authority Inspections, and early on in Flavia's time at Ascendis she was an instrumental member during one such European Inspection. Despite having only just joined the company, with her extensive clinical background she was able to support the team with important quality checks of the responses and played a key role in documenting Inspection-related requests where the clinical context was of critical importance to delivering appropriately to Inspectors. She maintained a calm demeanor during stressful situations and her detailed quality mindset enabled us to deliver efficiently. Outside of inspections, she was a fantastic clinical colleague, always ensuring that she put stakeholder engagement at the forefront. I would not hesitate to partner with Flavia again in the future.”
Contacts
Vortex Pharma Solution is headquartered in Copenhagen DK. We provide services remotely worldwide and in-person on demand. Please contact us to further discuss how we can assist you.
Phone:
+45 6022 9998
Email:
contact@vortexpharmasol.com
Location:
Hjortevænget 32, 2880 Bagsværd - Denmark
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VAT ID: 43009672