^SINGAPORE, April 05, 2023 (GLOBE NEWSWIRE) — Novotech, the leading, im
Asia Pacific-based biotech contract research organization (CRO),
has commissioned GlobalData to prepare a report on the evolving FDA
Biotech company approval process in Asia Pacific, in
Europe and the US to create also typical obstacles to success
should describe.
GlobalData’s report outlines the global regulatory landscape that
Pathways to admission, some common missteps to avoid, the
Importance of formulating a robust clinical development program and
what to expect from your CRO to guide the process for success
optimize.
The new Navigating the FDA Requirements: Capitalize on Regulatory report
Expertise To Simplify the Complex (Navigating the FDA Requirements:
Using regulatory expertise to simplify the complex) can be found here
be downloaded.
The report includes the following:
* Global approval landscape
* Overview of the US FDA approval process
* Variation in conventional clinical pathway
* Designations for accelerated approvals
* Drug approvals in the United States
* Typical obstacles to regulatory success
* Benefits of partnering with CROs
The report also notes that the FDA has a strict
study design has always given high priority?
FDA’s definition of what is meant by “strict study design”,
over time due to new scientific and technological
advances and as a result of changes in regulatory requirements and
of the general situation in the healthcare sector.”
* Greater focus on patient-centric outcomes: The FDA is putting bigger ones
Emphasis on incorporating patient-centric outcomes into clinical ones
Studies, ie to evaluate the effects of a treatment on the
symptoms reported by patients, quality of life and others
Aspects that are important to patients. This change has
Development of new approaches in study designs, based on
Focus on patient-reported outcomes, e.g. B.
Patient preference studies and patient-oriented drug development.
* Use of novel study designs: The FDA has approved the use of novel
Study designs that promote clinical efficiency and effectiveness
studies can increase. Examples include adaptive designs where
the allocation of patients to the different study arms
Dependency on intermediate results can be changed (adaptive
randomization). This study design, which is particularly relevant when
the primary endpoint can be measured quickly, in particular
popular during the Covid pandemic. Platform studies enable the
simultaneous testing of multiple treatments for a given disease.
These innovative study designs present numerous statistical
Challenges that require solid specialist knowledge to be mastered.
* Advances in data collection and analysis: The technological
Progress has led to new methods of data collection and analysis,
e.g. B. the use of portable devices and electronic
health records. These new data sources have the potential to
improve study design and reduce the burden on study participants
reduce the risk associated with traditional study paradigms. this will
as a promising avenue to accelerate clinical development
viewed.
* Changes in regulatory requirements: Formal changes to the
Regulatory requirements have also defined the FDA for one
strict study design influenced. For example, the FDA has guidelines
for the use of biomarkers in clinical studies as well as for the
Collection of safety data in early phases of clinical trials
issued.
Novotech has decades of experience in biotechnology
drug development, has established relationships with trial sites and
study physicians, access to large patient populations and a
Project management approach that focuses on problem solving, ownership and
flexibility focused.
Consistent investment in advanced training and technology
for an exceptional full-service biotechnology CRO solution.
Novotech has recently been recognized with major CRO awards including
Frost & Sullivan’s “Asia-Pacific Biotech CRO of the Year” award,
ranking as one of the top 10 CROs among the world’s leading CROs,
the nomination as a finalist at the prestigious Scrip Awards and the
Presentation of the Gene & Cell Therapy Excellence Award.
In Asia Pacific, Novotech has more than 50 Leading Site Partnership
Agreements with major medical research institutions
closed, which offer the sponsors exclusive advantages.
Novotech, which has CROs and regulatory advice worldwide, gave up
announced the acquisition of EastHORN, a
European CRO with clinical, medical and regulatory expertise
several strategically important locations on the continent.
The acquisition is part of Novotech’s global expansion program. EastHORN
was founded in 2004 and has over 250 employees.
The acquisition of EastHORN means customers in the biotechnology industry
throughout Europe and the USA access to the unique and unparalleled offer
Have early to late stage CRO services from Novotech. The
However, the focus is on the Asia-Pacific region, where the
Company has a good reputation for expedited execution
high-quality clinical studies.
About Novotech Novotech-CRO.com (https://novotech-cro.com/)
Novotech is the leading CRO in Asia Pacific with worldwide
Implementation options. Novotech is a clinical contract research organization
with laboratories, Phase I facilities, consulting services for the
Drug development and FDA approvals expertise and has experience
with over 5,000 clinical projects, including clinical trials of the
Phases I to IV and bioequivalence studies. Novotech is able to customers from
the biotechnology industry in conducting clinical trials in Asia
Pacific Rim, USA and Europe. Novotech has
more than 3,000 employees worldwide and 33 offices in the USA, Europe and the
Asia Pacific.
Visit https://novotech-cro.com/contact for more information
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