FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with Active Lupus Nephritis

On January 22nd, 2021, for the first time, the Office of Food and Drug Administration (FDA) has approved oral medications for kidney disease caused by lupus, which is an autoimmune disease that causes irreversible kidney damage and increases the risk of kidney failure, heart complications and death. The drug, now known as LupkinisTM, is prescribed along with immune suppressants to treat adults with active lupus nephritis. With voclosporin being the active substance, LupkinisTM demonstrated significantly improved renal response rates compared to typical standard of care (SoC) in clinical trials. As being the first oral therapy for lupus nephritis (LN) to receive FDA approval, Aurinia Pharmaceuticals Inc. has achieved a milestone in terms of medical research and proven that the benefits of the product outweigh the known risks for the intended use.

For a lengthy period of time, doctors have found it difficult to effectively treat patients with lupus nephritis. The LupkinisTM approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – to be more efficient and safe in terms of treatment methods.

“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic,” said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “The FDA approval of LupkinisTM allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”

The phase 3 study enrolled 357 subjects with active LN from 142 centers in 27 countries, most were females of childbearing potential. Subjects were randomized to receive either voclosporin 23.7 mg BID (N=179) or matching placebo BID (N=178) for one year in combination with MMF and steroids. The primary endpoint was renal response at Week 52 as adjudicated by an independent Clinical Endpoint Committee (CEC).

The result of the primary endpoint was met: treatment with voclosporin resulted in a clinically meaningful and statistically significant higher renal response rate compared to placebo (40.8% vs 22.5%). The odds of responding were 2.65 times greater for subjects treated with voclosporin than placebo with an absolute risk reduction of 18.3%. Alongside with the result of the primary endpoint, the outcome of the secondary endpoints also achieved statistical significant in favor of voclosporin.  These data are clinically important as it has shown that an early improvement in proteinuria can be a strong predictor of positive long-term outcomes in LN.

Since December 2017, the phase 3 clinical trial of voclosporin has been conducted in Vietnam at 6 investigational sites: Cho Ray Hospital, Bach Mai Hospital, University Medical Center, National Hospital of Dermatology and Venereology, Nguyen Tri Phuong Hospital and 115 People’s Hospital with total 15 randomized patients. SMART Research Company has proudly taken part in this research as a local CRO in Vietnam and will continue to support the upcoming researches. The Quality Policy of SMART Research is to ensure the delivery of the highest standard of services and products to our clients, therefore, we are delighted to contribute to the outcome of the research and positively impact the lupus nephritis community.


Aurinia renal response in ACTIVE LUPUS With Voclosporin – full text view. (n.d.). Retrieved February 08, 2021, from https://www.clinicaltrials.gov/ct2/show/NCT03021499

FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with ACTIVE Lupus Nephritis. (2021, January 23). Retrieved February 08, 2021, from https://www.businesswire.com/news/home/20210122005501/en/FDA-Approves-Aurinia-Pharmaceuticals%E2%80%99-LUPKYNIS%E2%84%A2-voclosporin-for-Adult-Patients-with-Active-Lupus-Nephritis

FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with ACTIVE Lupus Nephritis: Aurinia Pharmaceuticals INC. (AUPH). (2021, January 22). Retrieved February 08, 2021, from https://ir.auriniapharma.com/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis

Releasing the guideline for study, trial, the marketing authorization and usage of Covid-19 vaccine.

During the complicated period of pandemic covid-19 around the world, it is important to study and be active in stock of covid-19 vaccine. Vietnam already has the quality management system of vaccine complied with WHO standards. However, the production of covid-19 vaccine can not be completed without the corporation of the government, the regulatory, the vaccine’s manufacturer, the researchers, the ethics committee board in biomedical research, the sponsors and the technical support partners. Vietnam is also one of 38 countries that have the vaccine regulatory complied with WHO standards.

During the meeting “Implementing study, trial and approval of the marketing authorization of covid-19 vaccine in Vietnam”, acting Minister Nguyen Thanh Long said: “We expect to be independent regarding covid-19 vaccine. It is important to accelerate the process of study to have covid-19 vaccine for Vietnamese people. At the same time, there is a need of regulation to access the supply of covid-19 vaccine in the world”.

To facilitate the studies using for vaccine’s manufacture and in the same time still ensure the safety and effectiveness for vaccine consumers, the Ministry of Health released decision No. 3659/QD-BYT regarding guideline for study, trial, the marketing authorization and usage of Covid-19 vaccine.

Administration of Science, Technology and Training (ASTT) department uploaded this decision for notification and action of related partners.



 Translator: CRA. Nguyen Mai Hang

Update From SMART Research About COVID-19 Pandemic Control in Vietnam

Updated to 6am, April 10th, 2020

As of 6am, April 10th, 2020, Vietnam’s Ministry of Health confirmed a total of 255 cases of COVID-19 and 0 cases deaths. The updated number remained the same as yesterday morning showing no new cases in the past 24 hours. In addition, 128 of the affected patients have recovered and discharged from hospitals. Besides, it is expected that 14 ones will be declared cured today.

As the coronavirus pandemic rages in over the world, Vietnam has a done a good job thus far in fighting the coronavirus. During the Tet New Year celebrations at the end of January, Vietnam’s government said it was “declaring war” on the coronavirus, although the outbreak at that time was still confined to China. Prime Minister Nguyen Xuan Phuc said during a meeting of Vietnam’s ruling Communist Party that it would not be long before the coronavirus reached the country. “Fighting this epidemic, means fighting the enemy,” said Mr.Nguyen. Having experience responding to SARS, avian flu, and other epidemics, Vietnam acted quickly on the early signs of COVID-19 in January. The authorities carried out selective testing and quarantined potential cases. Other measures followed one by one, including moves to close schools, ration surgical masks, cancel some flights, and then close entry to most foreigners. The government has also asked all citizens to fill out a health declarations online and sent regular text message updates nationwide. It gives daily updates on infections to the media, which reports each infected person as a case number and announces flights and locations linked to infections, asking people to report to the hospital if they have been on those flights or at those locations. In some situations where testing is ordered for entire buildings, managers ask residents to speak up if they know that neighbors are avoiding tests. The World Health Organization is among the groups that praised Vietnam for its virus response.

Furthermore, all the treatments, testing and quarantine activities and supplements related to the COVID-19 in Vietnam are FREE. On the other hand, Vietnam has announced a national lockdown to fight COVID-19, with nearly 100 million people ordered not to go outside except for food and medical needs, the most extreme measure taken yet after the nation had early success in limiting its first wave of infections. Prime Minister Nguyen Xuan Phuc signed a social distancing directive Tuesday dated Mar 31st, 2020 that requires people to stay inside for 15 days, starting Wednesday (Apr 01st, 2020).

SMART Research Business Continuity Plan for 2019 nCoV

As part of SMART Research Business Continuity Planning (BCP) related to the COVID-19 global pandemic, our focus is on protecting the health and safety of our employees and ensuring our customers’ operations continue as smoothly as possible during this difficult period. We continuously provide our staffs with in-depth information so that they can support our customers with the most up-to-date and relevant advice.

Currently the company already has 3 alternate teams of employees working in 3 separate offices therefore 3 teams are physically segregated to minimize the risk of infections between teams. Project team members of each project are reviewed to cross-train employees and establish covering arrangements to minimize disruptions to CRO services performed to Customers. Our staffs are deeply trained on infection control and good personal hygiene. Besides, an adequate supply of appropriate personal protection equipment such as disinfectants and masks are provided to the staffs for usage. In addition, SMART Research has implemented a work-from-home from Mar 17th, 2020 for Hanoi’s Office and from Mar 26th, 2020 for Ho Chi Minh’s Offices, to self-discipline, strictly adhered to the Directives of the Vietnam Government, which required no more than 10 persons in the same place.

Up to now, during the pandemic outbreak, our operations are still running smoothly and all our employees will return to normal work in accordance with the government’s decision-making spirit.

In conclusion, SMART Research is closely monitoring the COVID-19 pandemic as it continues to spread across the world, and taking steps to keep our employees, customers and communities in which we operate informed. We will continue to provide new information and resources on this page as they become available. Please do not hesitate to reach out to us if you need more information.

Best wishes for the world and all of us!

Vietnam, Apr 10th, 2020

SMART Research Corp.

SMART Research Corp.


Phu Yen, as known as the land of yellow flowers on green grass, welcomed SmartResearch family with cool weather full of sunlight and winds on 4th Jan 2019. All members were together on the bus from Tuy Hoa airport to Cendeluxe Hotel – Til the big family from two different areas of the country gathered, our 3-day happiness journey was really set out.

In the first morning, our teambuilding meeting was held in a dignified hall of Cendeluxe Hotel. The meeting brought up the precious opportunities for not only the experience sharing in regard to CRA’s obligations but also the 2-way connection in the company from the point of management. Dr. Tuan Ngo, Medical Director of SMART Research Corp., represented the Director Board to open the meeting, followed by Smart CRAs’ presentations to share their hands-on experience and clear up all relevant queries raised. Firstly, CRA Tran Cao shared his own experience obtained in operating workshops in hospitals. Then, CRA Phuong Nguyen delivered a useful presentation detailing preparations for incoming Sponsor audit. In the following sharing, CRA Thao Pham and Liem Nguyen worked on ISO-a procedure system has been launched and being built by Smart QA. In the clinical research field, the co-operation between CRAs and SCs remains everlasting matter with which was concerned in CRA Nhu Vo’s presentation. He also covered  some tactics to get the equilibrium in such relationship. Working in the on-field studies obviously requires particular skills to be able to work in specifically indigenous places. The relevant hands-on experiences were shared by CRA Duy Vu on Start-up and monitoring in malaria study conducted in Tay Nguyen-the high land area in the central of Vietnam. Finally, a mini teamwork exercise was hosted by CRA Truc Huynh in finding flaws on study documents which is an extremely essential skill for any CRAs to ensure the accuracy and completeness of data. The meeting ended up with blissfulness, the intriguing parts of the journey were waiting in Sala Hotel located nearby Tuy Hoa beach.


The series of teamwork activities occurred on consecutive three days tying the relationship between colleagues from different areas with different dialects but the same sanctuary-in clinical study field to speak our common voice. The Smart football championship was held on the beach with the result coming down to the wire after loads of nerve-racking penalties. At that ‘opened stadium’, we were pumped up to join in a whole host of active games, calling for our competitive as well as cooperative mindset. All the stress was released, all the molds that we jammed ourselves into at work were thrown off, we were one in a picture with the most cheery smiles.

the next evening, the Gala Dinner taken place in CendeLux Hotel once again brought up all Smart family members together with nearly 20 auditions, demonstrating that music powerfully bridges any soul.

We freely spent the last day in Phu Yen on a tour to several allure destinations such as Dai Lanh cape where to pick the first sunrise on land in the country, Yen island with picturesque views of unspoiled nature.

On the way to Tuy Hoa airport, everyone quietly starred Phu Yen city from the corners to the hospitable people before coming back. We couldn’t bring the beautiful long sand or immense blue sky back to our cities, however, all unforgettable memories when we were together in this charming place are eternally kept in our minds.

Tra Bui (CRA)

On 03 Nov 2018 Administration of Science Technology and Training – MOH cooperated with National Ethics Committee in Biomedical Research in holding the closing conference of the activities of Reviewing Board in Biomedical Research of the 2012-2017 tenure and the directions, tasks of National Ethics Committee in Biomedical Research of the 2018-2023 tenure.

On 03 Nov 2018, at The Reed Hotel located in Ninh Binh City, Administration of Science Technology and Training – Ministry of Health cooperated with National Ethics Committee in Biomedical Research in holding the closing conference of the activities of Reviewing Board in Biomedical Research of the 2012-2017 tenure and the directions, tasks of National Ethics Committee in Biomedical Research of the 2018-2023 tenure.


The conference was attended by the Executive Board of Administration of Science Technology and Training – Ministry of Health, the members of National Ethics Committee in Biomedical Research, the representatives of Hospitals, Institute’s, Pharmaceutical companies and Contract Research Organizations.


In this event, Administration of Science Technology and Training – Ministry of Health promulgated, explained and instructed the Circular No. 45/2017/TT-BYT dated 16 Nov 2017 on the establishment, functions, tasks, powers of National Ethics Committee in Biomedical Research; at the same time, ASTT also promulgated the Circular No. 29/TT-BYT dated 29 Oct 2018 on regulating Clinical Trials.

For the full text of  the Circular No. 29/TT-BYT dated 29 Oct 2018 on regulating Clinical Trials, please refer the link below:




At the point of time in the mid autumn, Hanoi, the ancient capital, immersed into condensed fair sunlight and cool breeze meanwhile Ho Chi Minh city was still in the hectic and busy pace of life under the heat spell, all members of SMART family from two distinct regions of the country were pumped up for the team building event taken place during the morning of 21st Sept 2018.

Prior to the meeting, all preparations were ensured carefully to be done within one week from meeting room, content, invitation, camera and other things in order to give the priceless moments for everyone when we are together.

In the team building day, the connecting line was set up between Novotel Sai Gon Hotel and Thang Long Opera Hotel to livestream the meeting simultaneously occurring in both locations. Initially, the Director Board had the first introduction and stated the meeting rationale in the formal settings, followed by the presentations of CRAs (Clinical Research Associate) who had been working for many years in clinical trials field.

Being fundamentally different from active and restless out-door activities, the event was highly appreciated due to the accumulated hands-on experience shared and precious advice enthusiastically given. Firstly, Dr Tuan Ngo, Medical Director of SMART Research Corp., had a consentive presentation giving an overview of Clinical Research in Vietnam. Then, the presentation regarding  study submission was given by Ms Truc Huynh, a CRA working in SMART Research Corp. for more than 6 years. In the next part, Mrs Huong Tran shared her experience in communication with relevant departments and administrations within Ministry of Health and Local Ethics Committees in particular, acquired during her long time working as a senior CTA (Clinical Trial Assistant). Needless to say, Clinical Study covers various procedures that arise the need of third party vendor’s involvement. The rule of engagement for third party vendor was delivered by Mrs  Xuan Tran, working in SMART Research in the role of a Clinical Project Manager.

It is undeniable that CRA is really a demanding job due to the coordination with various important parties and individuals. That is the reason why we find it crucial to know how to work with other staffs and sites which was shared by a senior CRA, Ms Huyen Le based on her experience. Being overloaded with work, a CRA faces up to deadlines on the regular basis that huddles oneself beyond task accomplishment in a timely manner as well as the life balance. Dr. Nguyet Tran,  General Manager of SMART Company, had such an informative sharing about Eisenhower Matrix and Planning offering an effective way for time management and work-outcome improvement. Any question raised after either sharing all boils down to the passion of individuals in SMART family for study field which has just been introduced into Vietnam for roughly a decade. In the subsequent part, the atmosphere was completely changed with personal introductions, an ice-breaker that once again brought us together. Loving smile was the only thing that could tell more than words. Finally, the meeting ended up with photos taken to keep our memorable moments and a cozy meal in a big family.

SMART Research staffs  did have a great day with experience exchange, and the opportunity bringing all members together. After all, the event fosters our proudness towards SMART Research as the young company (established in 2011) with significant expansion to become the CRO employing the largest number of staffs (40 employees, including 21 CRAs) in Vietnam.  The Company offers the supportive working environment in which every individual is encouraged to reach the better version of himself. Regarding to the sustainable development, SMART Research gradually asserts its position in Clinical Trial field of Vietnam and international market. After all, our slogan is appealed obviously than ever in the team building event: TOGETHER, WE CAN BE SMARTER.