Our bioanalytical services assist our customers in every stage of their molecule development.

Our bioanalytical services assist our customers in every stage of their molecule development. We established our first bioanalytical laboratory in Taiwan in 1997, and we have subsequently established or acquired three additional bioanalytical laboratories. Our bioanalytical laboratories are among the earliest in North America that use liquid chromatography with tandem mass spectrometry (LC-MS/MS) assays, which is a powerful analytical chemistry technique that combines the physical separation capabilities of liquid chromatography with the mass analysis capabilities of mass spectrometry. 

We have about 40 employees at our three laboratories and 34 LC-MS/MS machines. We completed over 250 laboratory projects since 2020 and have completed over 239 validated assays. We have capacity to process approximately 12,000 samples per month (representing 700 samples per LC-MS/MS machine per month). 

Central Laboratory Services

Our central laboratory services include:

• Clinical core laboratory testing. We provide high-quality control programs to ensure every step of testing, from specimen requisition to laboratory report, is seamlessly managed through the implementation of globally-recognized quality standards and laboratory automation systems. These services include hematology and coagulation, chemistry and immunoassays, genomics and molecular assays, urinalysis and protein analysis. To meet the niche needs for immunotherapy, cell therapy, and prophylactic and therapeutic vaccines development, we have established a number of methods for cell surface marker analysis using the flow cytometry assay.
• Immunochemistry for biologics. We have strong capabilities in bioanalytical method development and validation for large molecular therapeutic drugs on PK, anti-drug antibody and neutralizing antibody assays with more than 100 analytes. 
• Biomarkers. Our experts work closely with our customers, assisting them in identifying appropriate biomarkers, analyzing regulatory approaches from fit-for-purpose to full compliance, selecting the suitable analytical technology or method, and developing and validating specific assays.
• PBMC processing. We process PBMC (peripheral blood mononuclear cells) in applying our robust proprietary methods and can create customized SOPs upon our customers’ request. Our extensive logistics network enables us to transport specimens from clinical trial sites from a majority of the sites across Greater China to our facilities within the expected timeframe based on stability requirements. We can process PBMCs according to our standard SOPs on the day of receipt, if required. We provide long-term storage in gas phase liquid nitrogen tanks.
• Alliance source for testing. We have created a strong network across the North America region with alliance laboratories that have specific expertise in different fields. Additional services that we can provide through this alliance include anatomical pathology; molecular pathology; cell-based assays and flow cytometry; single nucleotide polymorphism (“SNP”) genotyping; next-generation sequencing; heavy metals assays; drugs and narcotics testing; newborn screening; and mass spectrometry.
• Laboratory data management. Our laboratory information management system is access-controlled with high-security systems and a complete audit trail to ensure the competence of all data. Our services include project-specific database construction; daily and monthly third-place backup; demographic verification; panic alert; exclusive alert and customized data alert services; and electronic data generation and transfer. We also have the ability to access and monitor nearly real-time data of clinical trials.
• Bio-storage. We provide 24-hour security and 24-hour monitoring systems for bio-sample storage, including gas-phase liquid nitrogen tanks, deep freezers, freezers, refrigerators, controlled room temperature environments, and special storage services for PBMCs.
• Kit supply. We provide protocol-specific laboratory kits and other supplements, such as instruction manuals, project-specific kits, import/export permit applications, and expiry date tracking and reminders, to ensure the quality and accuracy of our customers’ studies.
• Bio-sample logistics. We provide a variety of solutions for bio-sample transportation to meet our customers’ requirements. These services encompass specimen shipment coordination services; in-bound and out-bound bio-sample shipments with SOP controls; ambient, refrigerated and frozen shipping conditions with temperature controls; domestic shipments within 6-, 24- and 48-hour requirements; and import/export permit applications including those for infectious bio-samples.
• Project management. Our project management team members have extensive experience in managing different types of clinical trials. Every project is assigned its own project manager. From the initial protocol review to project closure, we assist our customers at every stage in on-site training, laboratory instruction manual implementation, project monitoring and control, risk management, budget management, timely communication and resolution of issues, administrative support and coordination among sites, clinical monitoring teams, other laboratories involved in the studies and customers.

The landscape of Oncology in North America-region

Biotechnology companies are facing increased challenges around participant recruitment and retention, lengthy timeframes and relatively high costs.

For these reasons, we observed a fast-growing interest from biotechnology companies to include the North America-region for their Oncology drug development.

Because of lower risk of competing trials and high engaged sites and investigators, Oncology clinical trials involving the North America-region have historically recruited patients faster than other regions.

Oncology CRO services and Immuno-Oncology CRO services.

Biotechs looking for Oncology CRO services are coming to North America-region and increasingly partnering with regional CRO specialists with a similar fit in terms of culture and flexibility. About half of Greenline Clinical Research’s projects are in Oncology and Immuno-Oncology. Greenline Clinical Research has built teams with deep expertise in Oncology and Immuno-Oncology and strong connections with Oncology key opinion leaders and sites in the North America-region.

Greenline Clinical Research has built solid and long-lasting relationships with investigators allowing to quickly identify and recommend the most appropriate sites for your study in Oncology. Site selection is essential to the success of clinical studies in Oncology.

Over the last 5 years, Greenline Clinical Research has partnered with numerous biotechnology companies and completed hundreds of projects in Oncology. Greenline Clinical Research has consistently provided high-quality Oncology CRO services through a flexible approach that suits the need of small and medium biotechnology companies.

Greenline Clinical Research experience in Oncology and Immuno-Oncology

Greenline Clinical Research has conducted over a hundred trials in Oncology including these Oncology and Immuno-Oncology indications:

Solid tumour clinical trials

• Bladder Cancer
• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Gastric Cancer
• Glioblastoma
• HCC, Hepatocellular Carcinoma
• Head & Neck Cancer
• Melanoma
• NSCLC, Non-Small Cell Lung Cancer
• Other
• Ovarian Cancer
• Pancreatic Cancer
• Prostatic Cancer
• Renal Cancer
• Sarcoma
• SCLC, Small Cell Lung Cancer
• Other Solid Tumours

Haematological malignancies clinical trials

• Chronic Lymphocytic Leukemia (CLL)
• Acute Myeloid Leukemia (AML)
• Lymphoma
• Myeloma
• Chronic Myelomonocytic Leukemia
• Non Hodgkin’s Lymphoma

Starting Your Clinical Journey with the End in Mind – the Value of a Drug Development Plan

Establishing an intelligent clinical development program pathway from the start is vital for clarity around the complex processes required to achieve product registration.

The Drug Development Plan (DDP) plan informs every part of the journey from budgeting, capital-raising, timelines, clinical phases, research partners, research locations, regulator engagement, staff hires and much more.

Ultimately a DDP describes the steps that are required to generate the evidence to support marketing authorisation and reimbursement.

An external DDP advising team needs to be expert across all regulatory affairs and product development including manufacturing, toxicology and medical writing, and planning should start from the pre-clinical development phase.

The planning process cuts risks including unexpected regulatory hurdles and cost, and ensures the drug’s progress aligns with investor expectations, as well as optimising resources throughout the clinical program.

It also covers CMC quality requirements, non-clinical requirements, the non-clinical animal studies required, and the type and scope of clinical studies to support the product registration.

In addition to the typical Phase I, II and III program, the DDP can highlight any extra requirements, or studies that might be needed to support the application, such as clinical studies in special populations, or drug interaction studies.

One of the most important processes is a commercial or competitor analysis of products on the market, or currently in development. This informs the kind of studies and information that will be needed to support the marketing authorisation of the product.

A robust DPP also identifies ways to accelerate drug approval. There are a range of processes that regulators offer in order to speed up drug development and approvals. They include orphan drug designation for a rare indications, and for truly exciting products that are impacting life-threatening disease there are options including breakthrough therapy and fast track designation programs.

DDP key points include:

Rationale :

Starting off with a scientific rationale for the development of the product, which includes a brief summary of the target indication, and why the product is being developed. This sets the scene for the product development.

Competitors :

An analysis of similar competitor products that are on the market or are currently in development. This is an important part of commercial analysis, but also provides useful information on the kinds of studies and information that will be needed to support the marketing authorisation of the product.

Target Markets :

The product targeting could be for global registration or a single region such as the North America-region with others such as the US and Europe to be added later in the development program.

Manufacturing :

An assessment of the manufacturing quality requirements at the different stages of development. Starting off with Phase I GMP, and then moving through to process validation for marketing authorisation.

Clinical Strategy :

The clinical trial strategy comprising Phase I, Phase II, Phase III, may expand if say other populations need to be considered, or there may be an opportunity for a compressed clinical development strategy.

Financial :

Commercial importance requires timelines and costs, or at least estimates, so a company knows how much to raise or how long it is going to take.

Decision Points :

Then finally, include key decision points in the development plan where you decide whether or not it is worthwhile to continue the development of that program.

Clinical Consulting :

Greenline Clinical Research provides expert consulting to biotechnology companies with regard to development and realisation of their Drug Development Plans (DDP) and global regulatory strategies driven by a highly experienced team based in Canada, Europe and the USA, covering:

• CMC/manufacturing,
• toxicology,
• clinical,
• medical
• regulatory affairs consulting services.

Greenline Clinical Research’s core services include:

• Developing clinical and drug development plans for biotechnology companies.
• Getting client’s products GMP-compliant and ready for clinical development.
• Designing and coordinating client’s GLP- compliant toxicology studies in support of human studies.
• Co-ordinating meetings with international regulators, including US FDA and European EMA, and helping clients ask optimal questions in order to elicit meaningful responses.
• Writing up all types of applications to regulators pre-IND, IND, CTA: orphan applications, paediatric investigational plans, through to New Drug Applications.
• Designing and writing protocols, investigator brochures and all modules in the Common Technical Dossier required for a marketing application.

Product Experts:

• Vaccines
• cell and gene therapies
• immunotherapies
• Antibodies (incl. Mabs and ADC’s)
• GMOs
• peptides and recombinant protein products

Liver Disease CRO Services

The landscape of Liver diseases in North America region :

Biotechnology companies consider locations in the North America region to access vast treatment-naïve patient populations and accelerate their clinical trials at lower costs. North America hosts some of the most active key opinion leaders and investigators in the field of hepatology with strong experience working with biotechnology companies.

Hepatocellular carcinoma :

Hepatocellular carcinoma (HCC) and bile duct malignancies are highly prevalent in North America, especially in South Korea where the prevalence rate is about 5 times higher than in Western countries.

Hepatitis infections as well as fatty liver diseases such as NASH, which are endemic in this part of the world, are known to markedly increase the risk of developing HCC and explain the high rates observed in North America.

About half of clinical trials initiated by biotechnology companies in HCC involved a country from North America region.

NAFLD and NASH :

Non-alcoholic fatty liver diseases (NAFLD) are one of the most common liver disorders in developed countries and are particularly prevalent in North American. About a third of all industry-sponsored clinical studies involve sites across the North America region.

Hepatitis :

It is estimated that at least 0.5 billion people have been infected with Hepatitis B Virus (HBV). The North America region represents 5% of chronic HBV patients globally.

Liver disease CRO services

Greenline Clinical Research has robust relationships with investigators allowing to quickly identify the best sites for liver disease clinical studies. Over the last 5 years, Greenline Clinical Research has provided high-quality Liver disease CRO services to numerous biotechnology companies using an approach adapted to the biotech model.

Greenline Clinical Research experience in Liver diseases trials

Greenline Clinical Research has conducted over 30 trials in liver diseases including the following indications:

• Hepatitis B (HBV)
• Hepatitis C (HCV)
• Hepatocellular carcinoma (HCC) and bile duct malignancies
• Non-Alcoholic Steatohepatitis (NASH)
• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Liver Transplant

Infectious diseases and Vaccines CRO services

Providing Infectious diseases services and Vaccines CRO services

Many biotechnology companies look at the North America-region for their trials in Infectious diseases and Vaccines due to the high prevalence of diseases such as Hepatitis (Hepatitis B, Hepatitis C), HIV and Influenza across the region.

Extensive experience gives our medical, regulatory, and Project Management team a deep understanding of the complexities of Infectious diseases and Vaccines trials. More specifically Green Line Clinical Research has extensive expertise in assisting Biotechnology companies with:

• Feasibility assessment and site selection
• Study and protocol design advice
• Patient enrolment strategies for both adult and pediatric populations

Greenline Clinical Research experience in Infectious diseases and Vaccines

• Clostridium Difficile Infections
• Cytomegalovirus infections (CMV)
• Genital warts
• Hepatitis B
• Hepatitis C
• Herpes simplex infections (HSV)
• HIV

Greenline Clinical Research experience in Rare and Orphan diseases

Greenline Clinical Research has conducted over 10 trials including these rare disease indications:

• Acromegaly
• Alport Syndrome
• Alpha1antitrypsin deficiency
• Cystic Fibrosis
• Down Syndrome
• Duchenne Muscular Dystrophy (DMD)
• Fabry disease
• Friedreich’s ataxia
• Gaucher’s disease

Clinical and Regulatory Strategy

Many biotechnology companies come to Canada to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 17.5% R&D cash refund scheme. Biotechnology companies then often look at locations in North America to tap into their huge treatment-naïve patient populations for their later phase clinical research.

Greenline Clinical Research is recognized as the North America-region full-service contract research organization (CRO). Greenline Clinical Research has been instrumental in the success of over 100 clinical trial projects of Biotechnology companies in key areas such as Immuno-Oncology, Infectious diseases, Vaccines and Orphan and rare diseases.

Greenline Clinical Research has provided CRO services across a broad range of indications and treatment modalities including Oncology CRO services, Infectious diseases CRO services, Vaccines CRO services and Orphan CRO services.

Trial protocols are increasingly complex and more and more sponsors are looking at running their clinical trials outside the USA to find patients in emerging markets such as North America . The FDA can be involved during the clinical development and it is recommended sponsors engage with the FDA early for their study discussion and endpoints to gauge FDA’s standpoint. The FDA have issued some guidance outlining their position on studies conducted outside of the US. Clinical studies outside the US need to be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects.