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Fast Facts on the Healthcare Industry in China:

  • The fastest growing region for the number of registered clinical trials is Asia-(clinicaltrials.gov).
  • The proportion of clinical trial studies conducted in China has grown in the past decade due to lower study costs, large patient population, faster patient recruitment & enrolment than any other region in the world.
  • China is the world’s fastest growing pharmaceutical market, projected to be ranked second by 2020 with revenues experiencing continued double-digit growth.
  • Almost 1/3 of China’s population will be over 60 by 2050- (United Nations).
  • In June 2017 the ChiCTR – Chinese Clinical Trial Registry – was accepted as the 4th WHO ICTRP Primary Register- to unite healthcare professionals to manage clinical trials in China.
  • China’s Food and Drug Administration CFDA requires clinical trial sponsors to register all trials (Phase I, II, III, IV) & bioequivalence testing within one month after pre-registration of the trial.
  • Understanding ICH GCP & CFDA GCP requirements is key to success for clinical trials in China.
  • Anticipate a lengthy approval process. It takes approximately 10 months for the CFDA to approve clinical trial applications
  • First-in-man Phase 1 studies are precluded from China. The CFDA requires some existing clinical data or long-term toxicology data before approving a clinical trial application.
  • Many pharmaceutical and biotech companies are attracted to China as an established base for clinical trials.
“Welcome to Fisher Clinical Services, Beijing. There are several reasons why China is of interest to global pharma companies– large patient pools of treatment naive patients; a wide spectrum of western pattern infection and chronic diseases; high patient recruitment, enrollment & retention rate; a talent pool of highly trained healthcare professionals; improved infrastructure; potential for cost savings.

Challenges also present themselves – regulatory hurdles; protracted timelines for clinical trial approval; ongoing healthcare reforms; different import/export requirements; cultural differences in the application of GCP and GMP as well as cultural and language barriers that need to be surmounted.

From importation to storage, to comparator sourcing, complex packaging projects and distribution of clinical supplies through to returns and destruction, the Fisher Clinical Services Beijing multi-lingual team of experts makes the clinical trial chain simpler and safer. Find out more about the services we provide to facilitate the smooth execution of clinical trials in China.”

Wei Dong, General Manager, Fisher Clinical Services, Beijing
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State-of-the-art facility in the capital of China.

Beijing Fast Facts:
Location: Northern China
Population: 21.7 million
Nearest Airport: Beijing Capital International Airport
Distance from Airport to Facility: 20 Km from Beijing Capital International Airport
Fun Fact: Beijing is the capital of the People’s Republic of China. Our facility is a one hour drive from the Great Wall of China, the largest man-made structure in the world.

City:
Beijing
Country:
China
Opened:
2007
Total Capacity:
4,500 m2
Secondary Rooms:
2
Cold Production Rooms:
4
10-20 Production Rooms:
1
Freezer Production Rooms:
1
Warehouse Capacity:
19,591 m3
Ambient Storage Capacity:
5,300 m3
Refrigerated Storage Capacity:
665 m3
Frozen Storage Capacity:
62 m3
Secondary Rooms:
468 m3
10-20 Production Rooms:
76 m3
Environmental Technologies:
Yes
Audited:
SGS
Comparator Sourcing:
Yes
Returns & Destruction:
Yes
Labeling:
yes
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Key Benefits for Sponsors:

  • A state-of-the-art GMP facility strategically located in the capital of China. Complies with EU GDP and GMP requirements maintaining high quality standards.
  • A domestic entry point with ability to import bulk shipments into Beijing and to store inventory in a secure, temperature controlled environment.
  • Proven track record of 99% on time delivery across China with the ability to deliver to Tier 3 cities and beyond.
  • Expertise having managed a high volume of studies across China – 330+ studies to date; 60+ cities in China including remote sites; 10,000+ shipments annually.
  • Multi-lingual team with proficiency in English and a true appreciation of cultural nuances, professionally accomplished in overcoming challenges faced when running clinical trials in China.
  • Expertise in complex labelling and packaging projects including double blind secondary packaging and labelling; complex kit assembly; manual walleting; precision labelling on vials; Just-In-Time labelling of supplies before despatch to investigator sites.
  • Additional ability to package & label under refrigerated (2-8◦C) conditions where stability data is limited.
  • Proficiency in managing “light sensitive projects.”
  • Ability to manage importation and exportation of supplies, reducing number of hand-offs and securing the chain of custody across the supply chain.
  • Excellent track record of obtaining import licences in a timely manner – 70 hours, with ability to achieve a quick turnaround in high value duty payments ; 200+ imports per year.
  • Facilitates seamless and fast customs clearance by managing all import/export documentation and ensuring clinical supplies stay within correct temperature specifications.
  • Specialists in supporting sponsors during pre-CTA application stage. Expertise in managing IIS studies and Phase I studies. Clinical Supply Optimization services assist sponsors with planning, forecasting and cost management of clinical trials in China. Project management expertise for domestic and global trials.
  • Expertise in sourcing comparator drugs, maintaining integrity of supplies across the supply chain.
  • Acts as a single interface for all parties involved in the controlled drugs supply chain.
  • Expertise in sourcing local packaging materials and ancillary supplies, e.g. drug delivery devices and monitoring devices. Local capability for carton design and label printing for secondary packaging projects.
  • Track record of realising cost and performance efficiencies when delivering to investigator sites, accessing remote areas & scheduling shipments to accommodate patient appointments.
  • High capacity for ambient (15-25◦C), refrigerated (2-8◦C) and frozen (-20◦C to ±5◦) IMP storage, handling and distribution of supplies.
  • Capability to reconcile the return, storage and disposal of unused clinical material and returned IMP.
  • Established in 2007, a reputable provider with a track record of excellence in defining best practice in the industry.

Complex double blinded packaging study demands operational excellence to meet looming FPI date

Our client, one of the top major pharmaceutical companies, approached us with a challenging study – a double blinded study with the added complexity of a light sensitive drug in extremely fragile ampoules, also requiring distribution to investigator sites in remote locations across China. The Sponsor, who had worked with Fisher Clinical Services in the past, initially approached the project management team to discuss the complexity of this new trial with a view to evaluating possible solutions to the hurdles it was facing.

Foreseen challenges included:

  • The IMP was a light sensitive drug in an ampoule which was very fragile. An ampoule is a small sealed vial which is used to contain and preserve a sample, usually a solid or liquid, in this case the light sensitive IMP. Extra care would need to be taken during the packaging and labelling processes as each fragile ampoule had to be protected from light at all times.
    The appearance of the active drug (IMP) and the placebo drug had to be identical.
  • Consideration had to be given to the best way to distribute these supplies to remote locations throughout China. Would standard cartons be of sufficient quality to hold the ampoules in place during transit?
  • Time was of the essence as the packaging volume was large with the FPI (First Patient In) date close.
  • The placebo drug would not be ready until a date very close to the expected FPI date.

With expectations set that Fisher Clinical Services Beijing would have the expertise to address these challenges, the Sponsor made the decision to request a one-stop service from Fisher Clinical Services Beijing for comparator sourcing, label and tamper seal printing, carton design, labelling and packaging, distribution, returns and destruction.

Team collaboration
Fisher Clinical Services Beijing nominated team members to work together to facilitate the smooth execution of this complex trial. In an effort to shorten the project timeline this team set up a weekly meeting with the Sponsor to discuss the study requirements with particular focus on what action could be taken to speed up the project deliverables. As Fisher Clinical Services has been exclusively focused on clinical trials for over 25 years, with an established network of GMP facilities across the globe, the team in Beijing was able to call on the expertise of subject matter experts worldwide to discuss their packaging, labelling and distribution challenges.

Securing placebo
It was known from the outset that the timelines for receipt of the placebo were close to the FPI date. Quick action had to be taken to secure adequate supplies of placebo within the given timeframe, i.e. before the FPI date, as the placebo had to be labelled and packaged in advance of distribution. The Fisher Clinical Services Beijing Sourcing Team did not delay in securing adequate supplies of placebo.

Advance preparation for labelling and packaging
The packaging volume was large with an impending FPI date looming and an anticipated delay in getting placebo supplies. In anticipation of this tight timeline a proactive approach was taken to prepare all label and carton packaging materials in advance of receipt of the placebo supplies. Fisher Clinical Services asked the Sponsor to provide a briefing so that a sample label and carton could be produced by Fisher Clinical Services at the early stages of this project. This sample was immediately reviewed and approved by the Sponsor so that Fisher Clinical Services could prepare all labels and packaging materials in advance of receiving the placebo supplies at Fisher Clinical Services Beijing.

Adapting procedures to address complexity
A batch record (BR) is a document gathering all process data on a particular process step. Batch records are produced in cGMP biomanufacturing. Usually batch records are created once all of the required materials and products are received and recorded in the GPMS system at the facility. However, due to the complexity of this study, Fisher Clinical Services Beijing took the decision to create the master batch record for this study in advance of the materials and products arriving at the facility. This helped to accelerate the approval process at the Sponsor level and at project management and quality assurance level. Having pre- approval of the Master Batch Record ensured a quick start of the packaging and labelling process once all materials were received for this particular study.

Double blinding capability
For this double blinded study the appearance of the active drug (IMP) and the placebo drug would have to look identical. Labels were designed especially for this one trial to meet specific measurements of the ampoule vials. Intense training was given to the technicians as this label was difficult to apply. Samples of the blinded label and the ampoules were provided to the technicians so that they could practice in advance of the project. By the time the project was ready to start the Fisher Clinical Services technicians were ready to apply the label correctly and with speed. It was decided to use the same team of technicians to package both the IMP and the placebo therebt maintaining consistency across all supplies.

Staffing levels, roles and responsibilities
Initial review of the requirements of this complex packaging project suggested an allocation of 3 technicians for each kit. However, Fisher Clinical Services decided to allocate 4 technicians to each kit which resulted in considerable time savings, optimizing the packaging process and saving ~35% total physical packaging lead time. Furthermore, additional measures were taken to address the light sensitive nature of the IMP. Each kit was assembled within a defined time allocation and with minimal exposure to light.

Due to the complexities of this packaging project, in addition to the standard reconciliation that is carried out for all studies at the completion of each project, Fisher Clinical Services conducted additional quality reconciliation measures for this project alone. Reconciliation was carried out for each kit completion and a daily reconciliation was also recorded.

Packaging complexity
Our packaging design teams were conscious of the fragility of the ampoules. The Fisher Clinical Services technicians were advised to handle the ampoules with extra care due to their fragility. Additional precautions were taken at all stages of the packaging process. All ampoules were put on a plastic box during the packaging process so as to avoid damage.

Distribution with care
Why take all that care when packaging and labelling without considering the distribution aspect of these supplies? Fisher Clinical Services Beijing has expertise in sourcing local packaging solutions and in designing new carton packaging to accommodate all types of clinical supplies. It was decided that customised packaging would need to be developed to hold the ampoules in place in the cartons – two layers of insert with 44 holes to hold the ampoules in place during transit and additional sponge padding at the bottom and also at the top of the carton. To this end all ampoules stood steadily and independently in each carton, ready for distribution to remote sites across China’s vast landscape.

In summary
This complex packaging and labelling project presented many challenges for the Sponsor and for Fisher Clinical Services Beijing from the outset. However, careful planning, attention to detail and teamwork combined with unparalleled global expertise, flexibility and operational excellence resulted in the smooth execution of this trial and FPI dates being met.