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THERAPEUTIC AREA

Oncology Clinical Research Organization (CRO)

Challenges with Data-related Oncology Trials

As a drug development company that is heavily involved in running oncology trials, it is vital that you find the right clinical research organization who is well experienced in the oncology therapeutic area. With unique challenges to overcome due to the complexity of oncology trials, selecting the right CRO will help you achieve your goals of improving patient lives. Oncology trials face many challenges in the collection, analysis and reporting of study data, and selecting a partner that is specializes in data instead of a traditional full-service CRO can make all the difference in your studies success.

 

Table of contents

Highly complex datasets

Due to the large amount of data capture and analyze because of multiple data points and a large range of endpoints, as well as the range of different data sources in your oncology trial, datasets are often highly complex.

Quanticate statistical programmers are experienced in producing complex datasets. Having worked on a range of different oncology indications and also other Therapeutic Areas (TAs), we are used to producing datasets which have data from multiple sources, large volumes of data, and standardizing such data for clinical trial reporting.

Working with third party vendors

Your trial will likely involve multiple vendors, with tumor markers, biomarkers and safety laboratory data coming from your chosen specialized vendors, as well as dosimetry data if a radiotherapy trial, it can be challenging to coordinate and project manage multiple vendors.

Quanticate is highly experienced in multiple vendor management. Having worked with some of the top pharmaceutical companies on their oncology studies we have also worked closely with their third party vendors to ensure all necessary data for oncology trials comes together and is centralized in one place ready for analysis.

Data Standardization

Your oncology data will likely come from multiple sources which you will have to be standardized to a single format for your clinical trial reporting and regulatory submission needs. Oncology studies require large efforts in data standardization, not only in converting non CDISC data into CDISC standards for regulatory submissions, but also of converting existing CDISC data into the same version across all sources and datasets.

As well as your data being standardized from different sources, you’re also likely to encounter data with multiple differences in terminology, make sure your adverse events, concomitant medication and medical coding data are consistent to your chosen industry recognized dictionaries. All of this requires additional mapping to CDISC and adds to the complexity and size of your oncology trial.

Quanticate has experience in managing many different data sources/vendors and combining all of these sources to create a consolidated database in standardized formats such as SDTMs and ADaMs. Having completed several CDISC mapping studies, our data experts are well revised in the latest CDISC guidelines and regulatory guidance. Our clinical data managers are well rehearsed in the most up-to-date medical dictionaries such as Meddra, WHODD and many more.

Handling Large Volumes of Data

With advances in technology and the potential for continuous data collection in real time, you’ll need to make sure you can handle this increased volume of data. You will need Clinical data management teams that understand the latest industry data collection methods. Plus, you’ll want to ensure your statistical consultants have a good understanding of these latest technologies too. This will ensure that all your relevant data from any mobile device or eSource technology can be captured in the design of your trial.

Once you have collected all your trial data, you’ll want to be sure your clinical trial reporting is able to support the use of big data theories and the most efficient statistical programming methodologies to handle large datasets and large volumes of data.

Quanticate is experienced in handling large volumes of data in clinical trial reporting and working on big scale long-term studies. Our CDM teams have worked across a range of modern eClinical and mobile devices for data collection. And our biostatisticians and statistical programmers have worked on many oncology and other therapeutic areas which have required a big data analysis approach.

Analysis of Real World Data

Your oncology trial may not have a comparator treatment arm and therefore you may require your historic control data to come from a real-world setting. Ensure your study is utilizing Real World Data, giving you the best chance of proving your investigation hypothesis from the most efficient data types available.

Quanticate has vast experience in alternative trial types and has successfully supported large pharmaceutical customers in regulatory approvals with studies that used real world evidence as the majority of their trial data, which was an industry first.

Meeting Timelines for Regulatory Submission Milestones

As your trial reporting is more advanced and requires more time and planning compared to other therapeutic areas, let Quanticate help you submit your studies on time, all the time.

With Quanticate’s experienced project management and data expertise, we’re here to successfully handle your large projects that involve tight timelines and help you meet your submission deadlines.

With experts across the globe and industry leading project planning software we have the breadth and capability to rapidly resource studies when required so all timelines are meet and quality isn’t jeopardized.

Selecting the appropriate Oncology Study Designs

Ensure your oncology trial is set up for success from the start. Make sure your study design helps you select the right dose which gets the correct balance between therapeutic efficacy and toxicity during your phase 1 dose finding study. Take a modelling-based approach instead of the traditional 3 + 3 design to allow more flexibility in your trial design and the opportunity to consider a better trade-off between therapeutic efficacy and toxicity.

Quanticate can provide support on selecting the appropriate study design and sample size using simulation-based methods for phase 1 dose finding studies. Simulations enable us to provide sample size estimates for various scenarios to aide decision making. We can also provide support in running the models and providing the data/reports required for the decision making at the reviews at the end of each cohort.

 Additional reporting for Safety Monitoring Committees

Find the resource you need for the additional reporting requirements to Data Monitoring Committees/Safety Monitoring Committees and Boards without jeopardizing the blinding of your oncology study.

Quanticate can supply independent resource who work separately from your main study team to work on any DSMBs required. We have also supported clients solely on their DSMBs reporting requirements in additional to their existing vendors.

Resourcing for Peaks and Troughs

Responding to peaks and troughs in your pipeline is vital for resource efficiency, idle workers can increase your drug development costs. Alternatively, not enough resource to handle the analysis required and you are at risk of failing to meet a regulatory submission deadline.

It is important to be able to respond to these variating requirements rapidly by ramping up or scaling down resources.

At Quanticate we offer flexible outsourcing solutions. Whether you require a whole functional team in an FSP model, or a single consultant on an ad hoc basis, we can quickly provide the right amount of resource to fit your requirements.

Working on single systems between sponsors and vendors

Due to the sheer size of some oncology studies it is important to ensure your vendor is able to work to a single agreed system, this can be either your internal system with your standard operation procedures or the vendors.

At Quanticate we are well experienced in learning client SOPs and train our team to work on your systems when large trials dictate an harmonious approach for trial analysis. We also provide consultancy and SOP writing to improve your own systems if required.

Efficacy endpoints

Ensure your efficacy endpoints are well defined in your trial so you that know how effective your treatment is when determining if cancers are improving or getting worse, quality of life improves and the impact on overall survival rates. All of these factors need to be analysed with the best clinical data methods and standardization.

Our team has worked on a range of oncology trials, with experience in different endpoints from RECIST criteria, confirmed and unconfirmed best overall response, disease control, best change in tumor size and progression free survival. We are well-versed in designing trials to ensure that, whatever your goal endpoints are, they are easy to measure to prove your treatments efficacy. We are skilled in the statistical programming required to analyze and report these endpoints and placing them into required CDISC standards for submission.

Real Time Oncology Review (RTOR)

Getting your oncology drug approved can be a lengthy process because of the long-term endpoints to prove treatment efficacy. Help speed up your approval process by utilizing the Oncology Centre of Excellence Real Time Oncology Review (OCT-RTOR) pilot program. RTOR enables a simpler study design with more short-term endpoints to help increase the time to approval. The FDA have access to key data ahead of time so they can perform reviews prior to the official submission.

Quanticate is privileged to have supported large pharmaceutical customers on their first RTOR pilot programmes, with this experience we can help you follow the right steps for this innovative approach to faster treatment approvals, so medicines can reach patients more rapidly.

Our Oncology experience

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successful studies across all clinical phases (I-IV); including post-surveillance

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different therapeutic indications, including Carcinoma, Leukemia, Lymphoma, Myeloma and Sarcoma 

months of oncology experience combined across our 50 experts

Our Oncology Therapeutic Area Indications Expertise includes:

Carcinoma (Solid Tumors)
  • Bladder Cancer
  • Advanced hepatocellular carcinoma (HHC) (Liver)
  • Advanced Solid Tumors
  • Biliary Tract Cancer
  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Carcinoid Tumors
  • Cholangiocarcinoma (Bile Duct Cancer)
  • Colorectal Cancer
  • Colorectal Cancer/Pancreatic Primaries
  • Head and Neck Carcinoma
  • Hepatocellular Cancer (Liver)
  • Hepatocellular Carcinoma (HCC) (Liver)
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Renal Cancer
  • Small Cell Lung Cancer
  • Solid Tumors
  • Tumor
  • Tumor Growth
  • Kidney Tumors
  • Metastatic Cancer (Multiple System)
  • Recurrent Glioblastoma Multiforme (GBM)
  • Tuberous Sclerosis Complex (Vital Organs)
Leukemia & Lymphoma
  • Blood Cancers
  • Chronic Myeloid Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Acute Promyelocytic Leukemia (APL)
  • Myelogenous Leukemia
  • Neutropenia
  • Neutropenia/Febrile Neutropenia
  • Wiskott Aldrich Syndrome
  • Chronic Lymphocytic Leukemia (CLL)
  • Lymphatic cancer
  • Cutaneous T Cell Lymphoma
  • Lymphoma
  • Non-Hodgkins Lymphoma (NHL)
  • Wiskott Aldrich Syndrome
  • Myeloma
  • Multiple Myeloma
Others
  • Bones and soft tissue cancer
  • Sarcoma
  • Pigment cell producing cancer
  • Melanoma
  • Advanced Melanoma

Support from start to finish of all oncology development stages

Study Start Up
  • Trial design and planning
  • Provide sample size estimates for a variety of scenarios to help aide the decision making process
  • Input into statistical sections of protocols
  • CRF development and review
  • Develop the Statistical Analysis Plan 
Study Conduct
  • Standardization
  • Data capture
  • Data cleaning
  • Data integrity
Data Analysis
  • Create CDISC datasets: SDTM and ADaM to the latest standards
  • Produce tables, figures and listings for interim and final analyses
  • Provide support for DSMB reporting
  • Write/review the CSR 
Regulatory Submissions
  • Medical writing for document preparation and submissions
  • Regulatory Submission Review
  • ISS/ISE:
    • Assist with planning
    • Write analysis/data integration plans
    • Produce integrated summaries
    • Write and review ISS/ISE report
    • Review CDISC datasets to ensure compliance 
Post Submission & Approval
  • Support rapid response questions from the regulatory bodies
  • Learning for future studies
  • Patient Safety Profiles and on-going pharmacovigilance reporting
  • Experience with phase IIIB/IV studies to meet post-approval reporting requirements and re-imbursement requirements
  • Support for publications and other post-marketing activities
Success!

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