CRO Insights that drive clinical research forward

Your trusted sources for CRO insights that inform, inspire, and lead the conversation in clinical research.

Explore our latest CRO insights

Whether you are a biotech startup, pharmaceutical sponsor, or industry stakeholder, our insights are designed to keep you informed and inspired! As a leading Contract Research Organization (CRO), we leverage our deep experience across regulatory, clinical, and operational domains to bring you timely, evidence-based insights. Whether you’re navigating complex global trials or exploring innovation in biotech development, our articles aim to support informed, forward-thinking decisions.

CRO Insights

Expertise, Scale, and Trust in First-in-Human and Early Development

Expertise, Scale, and Trust in First-in-Human and Early Development

Expertise, Scale, and Trust in First-in-Human and Early Development At Aixial, we believe early phase trials—especially first-in-human (FIH) studies—set the…

Sarcoma Oncology Research – An introduction

Sarcoma Oncology Research – An introduction

Sarcomas are a diverse and rare group of malignant tumors arising from mesenchymal tissues, including bone, muscle, fat, and connective tissue.

Brain Tumours-remaining an area of unmet need

Brain Tumours-remaining an area of unmet need

Brain tumours remain one of the most formidable challenges in medical science due to their complex biology, high morbidity, and limited treatment options.

ASCO 2025: Q&A with Aixial’s clinical research experts

ASCO 2025: Q&A with Aixial’s clinical research experts

Q&A with Aixial’s experts at ASCO 2025. Learn how we can drive success in complex oncology trials. Find us at Booth #27150.

World Ovarian Cancer Day and the important of clinical development

World Ovarian Cancer Day and the important of clinical development

Ovarian cancer is one of the most lethal gynecologic malignancies worldwide, often diagnosed at an advanced stage due to subtle or non-specific symptoms.

The Importance of Monoclonal Antibodies in Neurodegenerative Disease Research

The Importance of Monoclonal Antibodies in Neurodegenerative Disease Research

Monoclonal antibodies (mAbs) have revolutionized the landscape of neurodegenerative disease research…

Advancing research into Parkinson’s disease with Aixial Group

Advancing research into Parkinson’s disease with Aixial Group

On April 11, World Parkinson’s Day, we are reminded of the importance of research in improving treatments and finding a cure.

Supporting Patients with Rare Diseases: Aixial’s Role in Advancing Patient Journeys

Supporting Patients with Rare Diseases: Aixial’s Role in Advancing Patient Journeys

In the European Union, a rare disease is defined as one affecting fewer than 5 out of 10,000 members of the general population…

Advancing Cell and Gene Therapies

Advancing Cell and Gene Therapies

The field of CGT is revolutionizing modern medicine, offering potential curative treatments for diseases previously considered untreatable…

International Day of Women & Girls in Science

International Day of Women & Girls in Science

Honor women’s significant achievements in science and place a much-needed focus on girls entering Science, Technology, Engineering, and Mathematics (STEM) careers.

Utilising CROs for Effective Planning and Execution of Clinical Development

Utilising CROs for Effective Planning and Execution of Clinical Development

Ashley Hunter and Anna Yanaeva led an engaging discussion on the importance of “Utilising CROs for Effective Planning and Execution of Clinical Development”.

Writings with molecules and standards as main characters

Writings with molecules and standards as main characters

Clear communication is essential to drug development. At Aixial Group, our experienced medical writers know how to turn complex scientific data into clear, accurate documents.

A phase II basket trial of (IP) in combination with (drug) in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations

A phase II basket trial of (IP) in combination with (drug) in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations

Pancreatic cancer is the 12th most common cancer in the world and remains one of the deadliest, with a five-year survival rate of only 13%, despite recent progress.

Atomising cancer

Atomising cancer

Breakthrough — Radiopharmaceutical therapy represents a novel approach to treating cancer, utilising radioactive atoms to target and destroy malignant cells with precision, without affecting the patient’s healthy tissues.

A Phase II Open -Label Safety and Efficacy Study of combination IP in patients with progressed advanced malignancies

A Phase II Open -Label Safety and Efficacy Study of combination IP in patients with progressed advanced malignancies

Did you know that lung cancer is the most diagnosed cancer in the world? In 2022, it accounted for 12.4% of all new cancer cases and 18.7% of deaths.

Safety, Preliminary Efficacy and Pharmacokinetics of [IP] in Metastatic Castrate Resistant Prostate Cancer

Safety, Preliminary Efficacy and Pharmacokinetics of [IP] in Metastatic Castrate Resistant Prostate Cancer

Prostate cancer is on the increase globally, especially in men under the age of 50, and in 2022 there were 1.47 million new cases.

Breast Cancer and Aixial Group’s Expertise

Breast Cancer and Aixial Group’s Expertise

In recognition of Breast Cancer Awareness Month, Ashley Hunter, Head of Strategic Development and Delivery…

Conflict of Interest in Clinical Trials 

Conflict of Interest in Clinical Trials 

One of the biggest challenges for researchers today is the threat of a conflict of interest in clinical trials (COI).

What Are The 4 Phases Of Clinical Trials?

What Are The 4 Phases Of Clinical Trials?

Clinical trials are designed to make sure that new treatments are better than existing ones. To do this, trials are structured by a framework that is made up of phases.

What Are Decentralised Clinical Trials? 

What Are Decentralised Clinical Trials? 

Decentralised clinical trials are a type of trial design used by studies to collect data from their participants. How data is collected can impact the trial’s efficiency, accuracy, and overall success and outcome.

How to prepare effective regulatory documents?

How to prepare effective regulatory documents?

Insights from Matilde Thye Kveiborg, Director of Medical Writing and Tanja Jensen, Senior Medical Writer

Demonstrating product value from multiple endpoints in rare disease trials

Demonstrating product value from multiple endpoints in rare disease trials

Rare diseases are often multifaceted, and a single endpoint is often not sufficient to fully describe treatment

Experts in Radiopharmaceutical Development

Experts in Radiopharmaceutical Development

Radiopharmaceutical therapy utilizes radioactive atoms to target and precisely treat cancer cells.

Mechanistic evidence by the HTA bodies

Mechanistic evidence by the HTA bodies

At the bottom of the EBM hierarchy, mechanistic evidence is not highly valued by the HTA bodies responsible for…

Indirect treatment comparisons

Indirect treatment comparisons

Lionel RIOU FRANÇA, Chief Scientific Officer, was involved in two analyses involving patients with Late-Onset Pompe…

For a reasoned therapeutic revolution in cell and gene therapy…

For a reasoned therapeutic revolution in cell and gene therapy…

Cell and gene therapies are multiplying, and with them the hopes of patients, their families, and healthcare professionals…

Rare Diseases: Phase I

Rare Diseases: Phase I

Conducting a Phase I First-In-Human (FIH) trial for Wilson’s Disease presents unique challenges due to the rarity…

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Case…

Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders

Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders

Aixial Group is currently collaborating with a US pharmaceutical company on a Phase II clinical trial involving paediatric patients with specific inherited metabolic disorders…

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Arm

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Arm

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Study Case study This case study looks…

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer Case study For a First In Human study,…

Early-Phase Oncology: First-In-Human Study in Advanced Solid Tumors

Early-Phase Oncology: First-In-Human Study in Advanced Solid Tumors

Early-Phase Oncology: First-In-Human Study in Advanced Solid Tumors Case study Read more For a First In Human study, site activation…

Rare Diseases: Phase II Primary Biliary Cholangitis

Rare Diseases: Phase II Primary Biliary Cholangitis

Conducting research in rare diseases like Primary Biliary Cholangitis (PBC) presents unique challenges due to limited precedents and small patient population.

Efficient Publication Strategy Leads to Expedited Submission and Acceptance

Efficient Publication Strategy Leads to Expedited Submission and Acceptance

Efficient Publication Strategy Leads to Expedited Submission and Acceptance Case study Since the World Health Organization (WHO) launched the Global…

Navigating the latest ICH E8(R1) Guideline Revisions

Navigating the latest ICH E8(R1) Guideline Revisions

Navigating the latest ICH E8(R1) Guideline Revisions Read more Becoming fully compliant with the latest and soon-to-be released ICH E8(R1)…

RBQM for Decentralized Trials: Two key areas of focus to reduce your risk

RBQM for Decentralized Trials: Two key areas of focus to reduce your risk

Since ICH-GCP E6 R2 made Risk-Based Quality Management (RBQM) ‘official’ back in 2017, we’ve seen an increased uptake…

Aixial FSP models: Expand your data management and biostatistics capabilities

Aixial FSP models: Expand your data management and biostatistics capabilities

Aixial FSP models: Expand your data management and biostatistics capabilities Whatever your existing study team structure and study data output…

Data Science & Analytics

Data Science & Analytics

Data Science & Analytics Data science and analytics solutions to fit your needs perfectly. Enhance the power of your trials…

Our experience in First-In-Human and Early Phase Oncology Trials

Our experience in First-In-Human and Early Phase Oncology Trials

Our experience in First-In-Human and Early Phase Oncology Trials Overview of Aixial Group’s in-depth experience in the areas of First-In-…

Top 10 Things to Look for in a Specialist Data & Analytics CRO Partner

Top 10 Things to Look for in a Specialist Data & Analytics CRO Partner

Top 10 Things to Look for in a Specialist Data & Analytics CRO Partner This helpful resource takes the guess…

Expert Medical Writing For Your Every Need

Expert Medical Writing For Your Every Need

Expert Medical Writing For Your Every Need Our medical writing experts can help you tailor a complete range of regulatory…

Commitment to Patient Centricity and Diversity: Key ingredients for a successful trial

Commitment to Patient Centricity and Diversity: Key ingredients for a successful trial

Commitment to Patient Centricity and Diversity: Key ingredients for a successful trial November marks the start of Movember, an annual…

Omicron Presents New Challenges for Early Phase Trials

Omicron Presents New Challenges for Early Phase Trials

Omicron Presents New Challenges for Early Phase Trials The evolving coronavirus disease 2019 (COVID-19) pandemic continues to present challenges for…

How to report clinical trials affected by the COVID-19 pandemic: Dealing with extraordinary circumstances

How to report clinical trials affected by the COVID-19 pandemic: Dealing with extraordinary circumstances

How to report clinical trials affected by the COVID-19 pandemic: Dealing with extraordinary circumstances Since 2020, the COVID-19 pandemic has…

Flexibility and Speed In Early Phase Clinical Trials

Flexibility and Speed In Early Phase Clinical Trials

Flexibility and Speed In Early Phase Clinical Trials Written by Crista Casey, Executive VP Global Head of Operations First and…

How to Cut the Negative Impact of Protocol Amendments

How to Cut the Negative Impact of Protocol Amendments

How to Cut the Negative Impact of Protocol Amendments May 8, 2023 Social distancing laws in response to the COVID-19…

We were ready for COVID-19

We were ready for COVID-19

At Aixial Group, we deployed some immediate response measures like providing our holistic platform not for profit for COVID-19 trials and our ongoing business…

Recipe for Success in Radiopharmaceutical Studies

Recipe for Success in Radiopharmaceutical Studies

Recipe for Success in Radiopharmaceutical Studies Read more Written by Sue Batchelor, Senior Director, Clinical Operations and Delivery Radiopharmaceutical studies…

Cervical Cancer and the Call to Eradicate It

Cervical Cancer and the Call to Eradicate It

Right now, a global movement to eliminate cervical cancer is being driven by the energy, passion and momentum…

Biotechnology’s Trusted Partner from Start to Finish

Biotechnology’s Trusted Partner from Start to Finish

Biotechnology’s Trusted Partner from Start to Finish Read more Aixial Group’s team of clinical experts can support your biotechnology company…

Bringing efficiency, reliability, and flexibility to your trials

As a full-service partner, as a FSP provider and as trusted consultants, Aixial Group focused on what truly matters to achieve positive outcomes. We are a specialized clinical development partner advising our sponsors to choose the best CRO solution and modalities for their clinical research and development needs.

  • Technology & Innovation Office
  • Aixial Lab
  • QMS

Our CRO service models: flexible solutions to meet your needs

As a Clinical Research Organisation, Aixial Group collaborates with sponsors to develop oncology, cell & gene, and rare diseases therapies. We provide innovative solutions to overcome the challenges and complexities faced by global biotech and pharma companies. We advise you to choose the best model for your clinical research and development needs.

  • Full-service partnership
  • Functional service provision
  • Consulting support

How can we support your next project?

Whether you’re looking for a protocol review or a proposal,

simply reach out to us by filling our request for proposal.