Our bioanalytical services support clients at every stage of their molecule development journey. Since establishing our first bioanalytical laboratory in Taiwan in 1997, we have expanded our capabilities by opening or acquiring three additional laboratories. Notably, our facilities were among the first in North America to adopt liquid chromatography-tandem mass spectrometry (LC-MS/MS), a highly effective technique that combines the separation power of liquid chromatography with the analytical precision of mass spectrometry.

Today, our three laboratories are staffed by approximately 40 experienced professionals and equipped with 34 LC-MS/MS instruments. Since 2020, we have successfully completed over 250 laboratory projects and validated more than 239 assays. With a monthly processing capacity of around 12,000 samples—averaging 700 samples per LC-MS/MS unit—we are well-positioned to meet the growing demands of bioanalytical testing.

Central Laboratory Services

Our central laboratory services encompass:

• Clinical Core Laboratory Testing
  We deliver end-to-end testing solutions, backed by rigorous quality control programs. From specimen requisition to result reporting, we maintain seamless operations through globally ecognized quality standards and automated laboratory systems. Our testing portfolio includes hematology, coagulation, clinical chemistry, immunoassays, genomics, molecular assays, urinalysis, and protein analysis. To support specialized needs in immunotherapy, cell therapy, and vaccine development, we have also developed a suite of flow cytometry assays for cell surface marker analysis.
• Immunochemistry for Biologics
  We offer robust capabilities in developing and validating bioanalytical methods for large-molecule therapeutics. This includes pharmacokinetics (PK), anti-drug antibody (ADA), and neutralizing antibody assays, covering more than 100 analytes.
• Biomarker Services
  Our biomarker experts work in close collaboration with clients to help identify the most suitable biomarkers for their specific study needs, supporting decision-making from early development through late-phase trials.

Biomarkers
Our specialists collaborate closely with clients to identify the most relevant biomarkers for their development programs. We provide guidance on regulatory strategies, from fit-for-purpose approaches to fully compliant validations. Additionally, we assist in selecting the most appropriate analytical technologies and methods, and we offer comprehensive assay development and validation services tailored to specific biomarker needs.

PBMC Processing
We offer peripheral blood mononuclear cell (PBMC) processing using robust, proprietary methods, with the flexibility to develop customized standard operating procedures (SOPs) upon request. Leveraging our extensive logistics network, we ensure timely specimen transport from a majority of clinical trial sites across Greater China to our facilities, in line with stability requirements. When needed, PBMCs can be processed on the day of arrival according to our standard SOPs. We also provide long-term storage in gas-phase liquid nitrogen tanks for optimal sample preservation.

Alliance Testing Network
Through our established network of alliance laboratories across North America, we provide access to a wide range of specialized testing services. These include anatomical and molecular pathology, cell-based assays and flow cytometry, single nucleotide polymorphism (SNP) genotyping, next-generation sequencing (NGS), heavy metals analysis, drug and narcotics testing, newborn screening, and mass spectrometry-based assays.

Laboratory Data Management

Our laboratory information management system (LIMS) is designed with stringent access controls and robust security protocols, featuring a comprehensive audit trail to ensure data integrity. Our offerings include the development of project-specific databases, daily and monthly offsite backups, demographic data verification, panic alert systems, tailored notification services, and seamless electronic data generation and transfer. Additionally, we offer near real-time access and monitoring of clinical trial data.

Bio-storage

We offer comprehensive bio-sample storage solutions with 24/7 security and continuous monitoring. Our facilities include gas-phase liquid nitrogen tanks, ultra-low temperature freezers, standard freezers, refrigerators, controlled room temperature storage, and specialized PBMC storage services, ensuring sample integrity at all times.

Kit Supply

Our team provides customized laboratory kits tailored to each study protocol, including user manuals, project-specific components, support for import/export permit applications, and tools for tracking kit expiration dates. These services help maintain the consistency and precision of our clients’ studies.

Bio-sample Logistics

We deliver flexible and reliable solutions for bio-sample transportation to accommodate diverse project needs. Our services include coordination of specimen shipments, inbound and outbound logistics with SOP adherence, temperature-controlled transport across ambient, refrigerated, and frozen conditions, and domestic shipping that meets tight timelines (within 6, 24, or 48 hours). We also support import/export permit applications for infectious and non-infectious samples.

Oncology Landscape in the North America Region

Biotechnology companies are increasingly challenged by difficulties in patient recruitment and retention, extended timelines, and high operational costs in clinical trials. As a result, there is a rapidly growing trend among these companies to conduct Oncology drug development in the North America region.

This region offers a strategic advantage due to its lower competition among trials and highly engaged clinical sites and investigators. Historically, Oncology studies conducted in the North America region have achieved faster patient recruitment compared to other global regions.

Oncology and Immuno-Oncology CRO Services

Biotechnology companies seeking Oncology CRO support are increasingly turning to the North America region, where they find alignment with regional CROs that offer cultural compatibility and operational flexibility. Approximately 50% of Clinpacific life science solutions portfolio involves Oncology and Immuno-Oncology studies. Our teams bring deep therapeutic expertise and maintain strong relationships with key opinion leaders and top-performing sites across the region.

Clinpacific life science solutions has cultivated trusted, long-term partnerships with investigators, enabling us to swiftly identify and recommend the most suitable sites for each Oncology study—an essential factor in ensuring clinical trial success.

Over the past five years, we have collaborated with numerous biotech sponsors and successfully delivered hundreds of Oncology projects. Greenline consistently delivers high-quality, tailored CRO services that are especially well-suited for the needs of small to mid-sized biotechnology companies.

Clinpacific life science solutions Expertise in Oncology and Immuno-Oncology

Clinpacific life science solutions has successfully managed and supported over a hundred Oncology clinical trials, covering a wide spectrum of Oncology and Immuno-Oncology indications. Our extensive experience includes trials for solid tumors and the following specific cancer types:

• Bladder Cancer
• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Gastric Cancer
• Glioblastoma
• Hepatocellular Carcinoma (HCC)
• Head and Neck Cancers
• Melanoma
• Non-Small Cell Lung Cancer (NSCLC)
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Renal Cancer
• Other solid tumour indications
• Hematological Malignancies Clinical Trials

  Greenline Clinical Research has extensive experience in managing clinical trials for various hematological malignancies, including:

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

  Beginning Your Clinical Journey with a Clear Vision – The Importance of a Drug Development Plan

  Initiating a well-thought-out clinical development pathway from the outset is crucial for understanding the intricate steps involved in achieving product registration.

  The Drug Development Plan (DDP) outlines each phase of the process, covering aspects like budgeting, securing capital, setting timelines, clinical trial phases, research collaborations, study locations, regulator interactions, staffing, and more.

  Ultimately, the DDP provides a roadmap for generating the necessary evidence to secure marketing authorization and reimbursement.

  An external team advising on the DDP should possess expertise in all areas of regulatory affairs and product development, including manufacturing, toxicology, and medical writing. Planning should begin as early as the pre-clinical development phase.

  Key Points of the DDP:

  Rationale:
  The development process begins with a scientific rationale for the product, which includes a concise overview of the target indication and the reasons for developing the product. This helps to establish the foundation for the product’s development.

  Competitors:
  An assessment of comparable competitor products, both those already on the market and those under development. This section plays a critical role in commercial analysis, while also offering valuable insights into the types of studies and data required to support the product’s marketing authorization.

• Target Markets:
  The product may initially target a specific region for registration, such as North America, with plans to expand to other markets like the US and Europe later in the development process.

  Manufacturing:
  An evaluation of the manufacturing quality standards required at various stages of development, starting with Good Manufacturing Practice (GMP) in Phase I and progressing to process validation in preparation for marketing authorization.

  Clinical Strategy:
  The clinical trial strategy outlines the approach for Phases I, II, and III. It may be adjusted if additional populations need to be included, or if there’s an opportunity to streamline the clinical development process.

  Financial:
  The financial component is essential for determining the commercial significance, including setting timelines and estimating costs. This helps companies understand how much capital is needed and the expected duration of the project.

  Decision Points:
  The development plan should outline key decision points to assess whether it’s worth continuing the program, based on the outcomes and milestones reached at each stage.

  Clinical Consulting:
  CLINPACIFICS LIFE SCIENCE SOLUTIONS offers expert consulting services to biotechnology companies in crafting and implementing their Drug Development Plans (DDP) and global regulatory strategies. This is supported by a skilled team across Canada, Europe, and the USA, specializing in:

  • CMC/Manufacturing
  • Toxicology
  • Clinical Development
  • Medical Affairs
  • Regulatory Affairs

  Clinpacific life science solutions core offerings include:

  • Assisting biotechnology companies in developing clinical and drug development plans.
  • Ensuring clients’ products are GMP-compliant and prepared for clinical development.
  • Designing and managing GLP-compliant toxicology studies to support human trials.
  • Coordinating meetings with international regulatory bodies, such as the US FDA and European EMA, and helping clients frame optimal questions for meaningful feedback.
  • Preparing regulatory applications, including pre-IND, IND, CTA submissions, orphan designations, pediatric investigational plans, and New Drug Applications.
  • Developing and writing clinical trial protocols, investigator brochures, and all necessary components of the Common Technical Dossier for marketing applications

    Subject Matter Expertise:
    Clinpacific life science solutions team includes specialists with deep expertise across a wide range of product types, including:

  • Vaccines
  • Cell and gene therapies
  • Immunotherapies
  • Antibodies, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs)
  • Genetically modified organisms (GMOs)
  • Peptides and recombinant protein-based therapeutics.

Liver Disease CRO Services
The Liver Disease Landscape in the North America Region:

Biotechnology companies are increasingly looking to the North America region for liver disease clinical trials due to its access to large treatment-naïve patient populations and the potential to accelerate study timelines while keeping costs lower. This region is home to leading hepatology investigators and key opinion leaders with extensive experience collaborating with biotech firms.

Hepatocellular Carcinoma (HCC):

HCC and bile duct cancers are particularly common in North America, with countries like South Korea showing prevalence rates nearly five times higher than those in Western nations.

The high incidence of hepatitis infections and metabolic liver conditions like non-alcoholic steatohepatitis (NASH)—which are widespread in the region—contribute significantly to elevated HCC rates, making the area a strategic choice for liver disease clinical research.

NAFLD and NASH:

Non-alcoholic fatty liver disease (NAFLD) is among the most widespread liver conditions in developed nations, with particularly high prevalence across North America. Approximately one-third of all industry-led clinical trials targeting NAFLD and NASH include sites within this region, highlighting its importance in liver disease research.

Hepatitis:

Hepatitis B Virus (HBV) has affected an estimated 500 million individuals globally. The North America region accounts for roughly 5% of the world’s chronic HBV population, making it a key area for clinical development in hepatitis treatment.

Liver Disease CRO Services
Greenline Clinical Research has established strong and enduring partnerships with investigators, enabling rapid identification of optimal sites for liver disease clinical trials. Over the past five years, Greenline has successfully delivered tailored CRO services to numerous biotechnology companies, leveraging a biotech-aligned model that emphasizes flexibility and quality.

Extensive Experience in Liver Disease Clinical Trials
Clinpacific life science solutions has led more than 30 liver disease clinical trials across a range of indications, including:

• Hepatitis B (HBV)
• Hepatitis C (HCV)
• Hepatocellular carcinoma (HCC) and cholangiocarcinoma
• Non-Alcoholic Steatohepatitis (NASH)
• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Liver transplant studies

 CLINPACIFICS LIFE SCIENCE SOLUTIONS Expertise in Infectious Diseases and Vaccines

Clinpacific life science solutions has extensive experience managing clinical trials across a broad range of infectious diseases and vaccine-related indications. Our team has supported studies in the following areas:

• Clostridium difficile infections (CDI)
• Cytomegalovirus (CMV) infections
• • Genital warts
  • Hepatitis B Virus (HBV)
  • Hepatitis C Virus (HCV)
  • Herpes Simplex Virus (HSV) infections
  • Human Immunodeficiency Virus (HIV)

  Our proven track record in these therapeutic areas enables us to effectively guide biotechnology companies through complex trial requirements with efficiency and precision.

  Experience in Rare and Orphan Diseases

  Clinpacific life science solutions has successfully conducted over ten clinical trials focused on rare and orphan disease indications, including:

  • Acromegaly
  • Alport Syndrome
  • Alpha-1 Antitrypsin Deficiency
  • Cystic Fibrosis
  • Down Syndrome
  • Duchenne Muscular Dystrophy (DMD)
  • Fabry Disease
  • Friedreich’s Ataxia
  • Gaucher’s Disease

  Strategic Clinical and Regulatory Approach

  India is an attractive destination for early-phase clinical trials due to its streamlined regulatory pathways and a generous 17.5% R&D cash refund program. Many biotechnology companies leverage these advantages in the early stages before expanding their trials across the broader North American region, where access to large treatment-naïve populations supports efficient patient recruitment for later-phase studies.

  Clinical and Regulatory Strategy

  India has become a preferred location for early-phase clinical research, offering simplified regulatory pathways and an appealing 17.5% R&D tax rebate. As trials progress, many biotechnology companies expand into the broader North American

  region to capitalize on the substantial pool of treatment-naïve patients available for later-stage development.

  CLINPACIFICS LIFE SCIENCE SOLUTIONS stands out as a full-service CRO in the North America region, having played a pivotal role in the successful execution of over 100 clinical trials for biotech clients. Their expertise spans major therapeutic areas, including Immuno-Oncology, Infectious Diseases, Vaccines, and Rare/Orphan Diseases.

  With growing complexity in clinical trial protocols, sponsors increasingly turn to regions outside the U.S.—such as North America—to access diverse patient populations and expedite recruitment. While clinical trials can be conducted internationally, it is highly advisable for sponsors to consult the U.S. FDA early in the development process to align on study design and endpoints. The FDA has published specific guidelines regarding acceptance of data from non-U.S. trials, emphasizing adherence to Good Clinical Practice (GCP), approval by an independent ethics committee (IEC), and obtaining informed consent from all study participants.