OrphanDC acts on a consultancy-basis for pharmaceutical industries, setting up clinical trials in Latin America, providing them with environmental assessment and supporting soft-landing within the region.
Additionally, we support disease mapping, patient screening and recruitment. Furthermore, our Full-Service Patient Support facilitates operations and logistics for study subjects who need to travel abroad to participate in clinical trials.
OrphanDC was created based on values such as credibility, compliance, financial and social responsibility, diversity, time optimization, confidentiality, seriousness, among other cornerstones, focusing on having a transparent, relationship with our clients, partners, and service providers, always doing our best to increase patients' quality of life.
We aim to liaise companies and people, as well as provide our clients with the best consulting services to guide the decision-making process while executing clinical trials and doing business in Latin America.
OrphanDC applies its knowledge, network, and experience to help our clients build their acting strategy in Latin America through several processes, focusing on Environmental Assessment, Market Access, Business Operations, Tax Consulting & Planning, Regulatory Affairs, Clinical Trials, among many others.
Within the Clinical Trial Cornerstone, OrphanDC has a special and unique approach, especially because we understand very deeply the overwhelming scenario below (info and data taken from the CB Insights Study THE FUTURE OF CLINICAL TRIALS).
The Drawn-Out Process
Considering the timeline involving Discovery & Pre-Clinical, Phases I/II/III of the Clinical Trial per se, and the FDA approval of a new drug, there is a myriad of obligations for the whole process to be successful.
Furthermore, just finding out if someone is eligible to participate in a rare disease clinical trial is a herculean task!
The average time frame of a Clinical Trial from start to finish is 7.5 years. And the approximate cost per drug during the whole process ranges from $161M to $2B.
Additionally, the patient's journey is extremely tough and exhausting, especially in rare diseases.
Therefore, the $65B CT Market needs a complete makeover.
The patient must navigate even more troubled waters to find and enroll in the proper rare disease trial, which usually happens when existing forms of treatment have previously failed.
Besides that, matching patients with trials is a time-consuming and challenging process. There are over 18,000 US clinical studies currently recruiting patients.
Why Clinical Trials Fail
It is easy to imagine failure when many sites still use fax to request and receive patient records from hospitals. Thus, it takes a great amount of time to consolidate data and determine screening and eligibility.
Because of that, around 80% of clinical trials fail to meet enrollment timelines.
The Data Challenge
When we keep in mind that even structured data can also become unstructured due to transmission methods, the problem is much more crucial.
Moreover, there is no standard format for data entry, neither there is a central repository of patient data.
With innovation and tech, we aim to change that.
The OrphanDC Approach
We keep the best relationship with government agencies, health ministries, PAOs, besides several other private institutions in LATAM. Therefore, we always act transparently when dealing with our clients, assuring responsibility, loyalty, adaptability to changes, and confidentiality during any clinical trial setting up process.
It is the biggest representative entity of the pharmaceutical industry in Brazil. It was founded in 1933 and it congregates almost 400 national and multinational companies, which represents more than 95% of the Brazilian pharmaceutical market.
OrphanDC follows its Code of Ethics.
It is the Brazilian Representative Association of Clinical Trial Organizations which represents the CROs.
Av. das Nações Unidas, 14.261 - 25º andar
WeWork WT Morumbi - Ala B
São Paulo/SP - CEP 04533-085
Tel: + 55 11 98319-0861