Services in Rare Diseases
Clinical Development Strategy
The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development.
Pharmaceutical companies should consider reducing drug development costs and time to market as commercially rare diseases drug development differs from traditional diseases and there are considerably few patients to take the drug, therefore.
Learn more on Pre-clinical Studies and Clinical Trials for Orphan Drug Development in Rare Diseases
Click here to understand Global Regulatory Pathways For Clinical Development Strategy
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Credevo offers various services in the pre-clinical and clinical stage of drug development such as study designs, and all pre-dossier submission services
Regulatory Services
Drug development in rare diseases, unlike traditional drugs, involves special considerations and regulatory approaches such as financial benefits, faster approvals, and less stringent clinical data requirements.
We understand various regulatory approaches with our regulatory expertise and practical knowledge in obtaining orphan drug designation and market approvals.
Clinical Trial Feasibility Services
Clinical trial feasibility is a process of evaluating the likelihood of conducting a particular clinical trial in a particular geographical region with the overall objective of optimum clinical trial completion in terms of timelines, targets and, cost.
Conducting clinical trial feasibility is crucial in rare disease clinical trials for the following reasons
- To identify the country which has a potential rare disease population available to recruit for the clinical trials
- To identify the country which has a potential rare disease population available to recruit for the clinical trials
- To identify the country which has a potential rare disease population available to recruit for the clinical trials.
- To find qualified investigators and capable sites that have previous experience in conducting rare disease clinical trials.
- To understand the regulatory scenario and local ethical requirements to initiate, conduct, and complete the trials.
- To obtain an overview of various timelines required for initiation, conducting, and completion of clinical trials.
Learn more about clinical trial feasibility and how it can help you
How to perform clinical trial feasibility on Credevo?
Conducting clinical trial feasibility is super easy on Credevo, with only two simple steps. Sign up to create the profile & Post brief details of your project, that’s it. You reach thousands of clinical investigators/sites.
No clinical trial feasibility checklist or tools required
Rare disease clinical trial feasibility studies conducted on Credevo
Various clinical trial feasibility studies were performed with clinical investigators & sites worldwide on Credevo. Some of these clinical trial feasibility reports are available for everyone to utilize and get benefited.
- Acute Myeloid Leukemia – AML
- Glomerulonephritis
- Amyotrophic Lateral Sclerosis – ALS
- Acute Unilateral Vestibulopathy
- Epidermolysis Bullosa, and many more
Acute Myeloid Leukemia – Phase I/II Clinical Trial Feasibility
Glomerulonephritis – Clinical Trial Feasibility
Epidermolysis bullosa – Clinical Trial Feasibility
Clinical investigators in rare disease clinical trials
Finding clinical investigators for clinical trials in rare diseases is very challenging as patients with a rare disease are very few and finding investigators who treat patients and can recruit for clinical trials is elusive.
How can I find clinical investigators for my clinical trial project on rare diseases in Credevo?
Credevo has a database with thousands of rare disease clinical investigators all over the world. You can either contact us at [email protected] or conduct feasibility with brief details of your project.
Clinical trial monitoring in rare diseases
Clinical monitoring is one of the most crucial areas of the Research & Development process for successful and timely delivery of quality, data makes in clinical trials and this is more critical in rare disease clinical trials.
Credevo follows an adaptive and intelligent monitoring strategy uniquely tailored to meet rare and very rare diseases, utilizing individual patient data points.
We understand that recruiting and retaining a sufficient number of patients will always produce quality data and reduce the financial burdens on the sponsors.
Learn more about Patient Recruitment Strategies in Rare Disease Clinical Trials
Rare disease clinical trial logistics
Clinical trial logistics in rare diseases often involve scattered geography, remote locations, agile delivery of substances, the limited or precise quantity of drug substance, the unpredictable shelf life of drugs, which makes the clinical trial shipment challenging.
Learn more on Clinical Trial Logistics in Rare Disease Clinical Trials
Credevo offers perfect solutions for clinical trial shipments for your rare disease clinical trials with flexible networks
What are the special strategies required in shipment for rare diseases?
Rare disease clinical trial sites are few, scattered and remote, for this a flexible agile supply chain design is required. Strategies to maintain the substance in determining temperature, Pre-supply of materials that don’t have an expiry and setting up depots for easy access. Dedicated delivery management team to meet unpredictable requirements, infrastructure to deliver directly to the Patient, etc.
Credevo understands the complexities that are often involved in rare disease clinical trials and offers DTP – Direct To Patient clinical drug delivery, DFP – Direct From Patient logistics.
For queries, contact us at [email protected]
Global Regulatory Support | Clinical Development Strategy | Clinical Trial Feasibility | Global Clinical Operations