Novotech CRO Awarded Frost & Sullivan Best Biotech CRO Asia-Pacific 2019
Known in the industry as the Asia-Pacific CRO, Novotech is now lead CRO services provider for the growing number of international biotechs selecting the region for their studies.
Reflecting this Asia-Pacific growth, Novotech staff numbers are up 20% since December 2018 to 600 in-house clinical research people across a full range of services, across the region.
Novotech’s capabilities have been recognized by analysts like Frost & Sullivan, most recently with the prestigious Asia-Pacific CRO Biotech of the year award for best practices in clinical research for biotechs for the fifth year. See other awards here.
Dinesh Sampath Rangaraj, Vice President Healthcare, Frost & Sullivan said:
“Novotech is internationally recognized as a leading regional full-service CRO in Asia- Pacific. The company has achieved colossal success in Phase I through IV clinical trials and established itself as a specialized biotech CRO in the region. In addition, with its international accreditation coupled with local knowledge, partnerships, and expertise, Novotech has reinforced its presence in Asia-Pacific.”
Key to Novotech’s success according to CEO Dr John Moller is the experience of the Novotech people on the ground in 11 countries.
“It all comes down to local knowledge.”
“We know Sponsors are drawn to the region because of the obvious benefits – cost, data quality, medical excellence and research teams, start-up times and access to 1.4 billion people in urban areas. But our customer feedback shows they want a CRO that understands country cultures and has the relationships with the medical institutions and leading investigators.”
“Language and cultures can be a real barrier unless you have local teams that streamline and manage the process and take real advantage of what the region can offer to the biotech sector,” he said.
Novotech has also been on a mission to lock-in powerful partnerships with leading medical and research institutions across Asia to accelerate quality clinical research for its clients. It has now signed 20 strategic partnerships with hospitals and research institutions giving access to some of the best specialty teams and vast patient populations.
See if the Asia-Pacific is right for your next study. Click here to view the checklist.
Novotech’s Asia-Pacific clinical research offers:
- Large patient population
- Few competing trials
- Efficient regulatory system
- Highly qualified and educated medical professionals
- Low operational costs
- Well supported IT infrastructure
- High level of GCP compliance
- Efficient trial management and logistics infrastructure
Novotech uses the best-in-class technology solutions:
- CTMS (OracleSiebel)
- EDC (MedidataRave, Oracle Inform)
- ETMF (Sureclinical)
- SAFETY (OracleArgus)
Novotech provides clinical development services across all clinical trial phases and therapeutic areas:
- Feasibility: Detailed feasibility to identify the optimal countries, sites and investigators for
- Clinical Services: Project management, patient recruitment, monitoring and SDV
- Central Lab: Protocol management, laboratory services, specimen management and patient blood collection services
- Biometrics: Advance adaptive clinical trial design with Data Management, Clinical Programming, Biostatistics, PK/PD Analysis and Modelling
- Regulatory: Ethics and regulatory submissions, drug importation and governance
- Independent QA Services: Accredited to ISO 9001
- Medical Services and Safety: Includes medical, protocol and clinical study report writing importation and governance
Q&A with Novotech Executives Radha Jha – Director of Medical and Regulatory and Andries Claassen – Director of Biometrics
Q. What perception do US biotechs have of the Asia Pacific and how can a CRO support them in their development in the region?
R. (Radha) With biotech companies investing in more complex and global programs and looking for efficient trial start-up and completion timelines, we see biotech sponsors increasingly considering locations outside of the US for their trials. Asia remains one of the fastest growing regions for biotech-sponsored trials and there is a growing interest from US biotechs to expand their clinical development here. While there are many benefits in running clinical trials in Asia, sponsors can often face fragmented markets and heterogeneous regulatory pathways. This increases the need to partner with a regional CRO specialist who understands the regulatory nuances of each country.
Q. How is Novotech adapting to the changing needs in the biotech sector?
R. (Radha) There is significant growth in Novotech’s Medical team with the addition of a specialist Clinical Development and Regulatory consulting arm that is especially attractive to Asian clients. The team has now 30 staff with capability to offer a full range of pre-clinical, regulatory, medical and pharmacovigilance consulting services in preparing products to enter clinical trials, provide medical and safety input during trial conduct, and finally support in registration, marketing and post-marketing approval. With careful planning upfront to support our client’s clinical development program, including the use of well-designed innovative protocols, we work hand-in-hand with our clients to effectively assist them with their product strategy.
Q. How is the demand from Biotech companies evolving in biometrics and how is Novotech adapting to these changes?
R. (Andries) Clinical trial designs are getting increasingly complex and the Asia-Pacific is now established as a preferred destination for drug development. This means that biotech companies are looking for more scalable solutions especially with regards to data quality and biometrics. Novotech also prioritizes investment in the latest technology. For example, we recently partnered with Medidata to help reduce the overall trial timeline and to provide our clients with better data visibility for improved decision-making. Novotech’s overall EDC solutions for capturing, managing and reporting patient data as well as centralised medical coding are world class and suited for all our client needs.
Q. Novotech has made considerable effort to structure its Biometrics activity, how will this affect your clients?
R. (Andries) The Biometrics team has grown to about 85 staff throughout Asia-Pacific and we make a point at retaining and growing our best talents. This means we now have the firepower to handle the full Biometric activities of global trials and not only of regional studies. This makes a huge difference for our clients looking at tapping into the benefits of each region for their global trials.