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The path to regulatory approval for your trial requires expert guidance in clinical development, including statistical design, trial deployment, real world solutions, and regulatory strategies.
High-quality medical writing is essential for regulatory compliance and conveying scientific research to diverse audiences. Medical writers play a key role in creating clinical, regulatory, and medical research documentation while ensuring compliance with regulations. Lack of clarity in medical writing can result in misinterpretation of data/information, potentially impacting development decisions.
How we help
Nonclinical development is a must in every drug development project as it determines a drug candidate's safety and efficacy before entering human trials in all phases of development. A thorough nonclinical development plan, where the right activities are executed at the right time, supports decision-making and project timelines. Nonclinical studies include pharmacology, toxicology, pharmacokinetics, and formulation development.
How we help
Whereas placebo-controlled randomized control trials (RCT) remain the gold standard, in some situations, single-arm trials have become an accepted way of assessing a new treatment intervention. The potential simplification of clinical development using single-arm trials and SCAs requires an experienced, multi-disciplinary team.
How we help
Incorporating commercial input early enough in Phase 2 (or before) clinical trial designs is crucial for optimizing launch plans and successful HTA/Market Access conversations. Without early consideration of pricing strategies and market access requirements, drug developers risk missing critical data collection opportunities, potentially hindering their ability to secure not only approval but also achieve favorable pricing conditions.
How we help
Drug developers often face challenges related to the inflexibility and unpredictability inherent in traditional clinical trial designs. Adaptive clinical trial designs offer a solution by allowing pre-specified trial protocol adjustments based on accumulating data, minimizing risks, and enhancing drug development efficiency.
How we help
A successful clinical strategy involves a systematic and forward-looking framework that encompasses several key components: clinical hypothesis, clinical endpoints and measures (PK/PD, biomarker, PRO), trial design, go/no-go milestone decision, patient population and more.
How we help
Many drug development projects fail due to constraints in time and funding. Defining the regulatory strategy early during development increases the chances of doing the right thing at the right time, minimizing the time and money spent. While deep scientific knowledge of the drug is key, every project faces regulatory challenges that must be managed soundly and discussed with the regulatory bodies. A clear regulatory path facilitates decision-making and increases the chances of reaching the market and the patients.
How we help
Good clinical project management is essential to the success of any drug or device development program. Effective management can ensure on-time, within-budget, and high-quality results. Managing clinical projects can be complex and time-consuming, requiring in-depth knowledge of clinical development regulations and guidelines.
How we help
Pharmaceutical development and CMC aim to ensure that the medicinal drug — every time it is administered to a patient — will be delivered to the right place, at the right time, and in the right amount. Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompasses all the information that describes the manufacturing process, quality control measures, specifications, and stability.
How we help
Clinical pharmacology is a vital part of drug development. A solid clinical pharmacology program will ensure that optimal doses are chosen for later-phase development and that labeling is sufficient for clinicians to prescribe the drug safely. Specialized expertise and deep understanding are often necessary to achieve accelerated timelines, cost savings, meet regulatory requirements, and for post-marketing support.
How we help:
High-quality medical writing is essential for regulatory compliance and conveying scientific research to diverse audiences. Medical writers play a key role in creating clinical, regulatory, and medical research documentation while ensuring compliance with regulations. Lack of clarity in medical writing can result in misinterpretation of data/information, potentially impacting development decisions.
How we help
High-quality medical writing is essential for regulatory compliance and conveying scientific research to diverse audiences. Medical writers play a key role in creating clinical, regulatory, and medical research documentation while ensuring compliance with regulations. Lack of clarity in medical writing can result in misinterpretation of data/information, potentially impacting development decisions.
How we help
Nonclinical development is a must in every drug development project as it determines a drug candidate's safety and efficacy before entering human trials in all phases of development. A thorough nonclinical development plan, where the right activities are executed at the right time, supports decision-making and project timelines. Nonclinical studies include pharmacology, toxicology, pharmacokinetics, and formulation development.
How we help
Nonclinical development is a must in every drug development project as it determines a drug candidate's safety and efficacy before entering human trials in all phases of development. A thorough nonclinical development plan, where the right activities are executed at the right time, supports decision-making and project timelines. Nonclinical studies include pharmacology, toxicology, pharmacokinetics, and formulation development.
How we help
Whereas placebo-controlled randomized control trials (RCT) remain the gold standard, in some situations, single-arm trials have become an accepted way of assessing a new treatment intervention. The potential simplification of clinical development using single-arm trials and SCAs requires an experienced, multi-disciplinary team.
How we help
Whereas placebo-controlled randomized control trials (RCT) remain the gold standard, in some situations, single-arm trials have become an accepted way of assessing a new treatment intervention. The potential simplification of clinical development using single-arm trials and SCAs requires an experienced, multi-disciplinary team.
How we help
Incorporating commercial input early enough in Phase 2 (or before) clinical trial designs is crucial for optimizing launch plans and successful HTA/Market Access conversations. Without early consideration of pricing strategies and market access requirements, drug developers risk missing critical data collection opportunities, potentially hindering their ability to secure not only approval but also achieve favorable pricing conditions.
How we help
Incorporating commercial input early enough in Phase 2 (or before) clinical trial designs is crucial for optimizing launch plans and successful HTA/Market Access conversations. Without early consideration of pricing strategies and market access requirements, drug developers risk missing critical data collection opportunities, potentially hindering their ability to secure not only approval but also achieve favorable pricing conditions.
How we help
Drug developers often face challenges related to the inflexibility and unpredictability inherent in traditional clinical trial designs. Adaptive clinical trial designs offer a solution by allowing pre-specified trial protocol adjustments based on accumulating data, minimizing risks, and enhancing drug development efficiency.
How we help
Drug developers often face challenges related to the inflexibility and unpredictability inherent in traditional clinical trial designs. Adaptive clinical trial designs offer a solution by allowing pre-specified trial protocol adjustments based on accumulating data, minimizing risks, and enhancing drug development efficiency.
How we help
A successful clinical strategy involves a systematic and forward-looking framework that encompasses several key components: clinical hypothesis, clinical endpoints and measures (PK/PD, biomarker, PRO), trial design, go/no-go milestone decision, patient population and more.
How we help
A successful clinical strategy involves a systematic and forward-looking framework that encompasses several key components: clinical hypothesis, clinical endpoints and measures (PK/PD, biomarker, PRO), trial design, go/no-go milestone decision, patient population and more.
How we help
Many drug development projects fail due to constraints in time and funding. Defining the regulatory strategy early during development increases the chances of doing the right thing at the right time, minimizing the time and money spent. While deep scientific knowledge of the drug is key, every project faces regulatory challenges that must be managed soundly and discussed with the regulatory bodies. A clear regulatory path facilitates decision-making and increases the chances of reaching the market and the patients.
How we help
Many drug development projects fail due to constraints in time and funding. Defining the regulatory strategy early during development increases the chances of doing the right thing at the right time, minimizing the time and money spent. While deep scientific knowledge of the drug is key, every project faces regulatory challenges that must be managed soundly and discussed with the regulatory bodies. A clear regulatory path facilitates decision-making and increases the chances of reaching the market and the patients.
How we help
Good clinical project management is essential to the success of any drug or device development program. Effective management can ensure on-time, within-budget, and high-quality results. Managing clinical projects can be complex and time-consuming, requiring in-depth knowledge of clinical development regulations and guidelines.
How we help
Good clinical project management is essential to the success of any drug or device development program. Effective management can ensure on-time, within-budget, and high-quality results. Managing clinical projects can be complex and time-consuming, requiring in-depth knowledge of clinical development regulations and guidelines.
How we help
Pharmaceutical development and CMC aim to ensure that the medicinal drug — every time it is administered to a patient — will be delivered to the right place, at the right time, and in the right amount. Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompasses all the information that describes the manufacturing process, quality control measures, specifications, and stability.
How we help
Pharmaceutical development and CMC aim to ensure that the medicinal drug — every time it is administered to a patient — will be delivered to the right place, at the right time, and in the right amount. Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompasses all the information that describes the manufacturing process, quality control measures, specifications, and stability.
How we help
Clinical pharmacology is a vital part of drug development. A solid clinical pharmacology program will ensure that optimal doses are chosen for later-phase development and that labeling is sufficient for clinicians to prescribe the drug safely. Specialized expertise and deep understanding are often necessary to achieve accelerated timelines, cost savings, meet regulatory requirements, and for post-marketing support.
How we help:
Clinical pharmacology is a vital part of drug development. A solid clinical pharmacology program will ensure that optimal doses are chosen for later-phase development and that labeling is sufficient for clinicians to prescribe the drug safely. Specialized expertise and deep understanding are often necessary to achieve accelerated timelines, cost savings, meet regulatory requirements, and for post-marketing support.
How we help:
The path to regulatory approval for your trial requires expert guidance in clinical development, including statistical design, trial deployment, real world solutions, and regulatory strategies.
Our award-winning statistical and predictive software solutions, combined with our exclusive global datasets, will give you the quantitative edge you need.
Clinical trials are complex, time-consuming, and costly. But what if you could use simulation to guide your decisions and optimize your trial design?
In this webinar, we'll discuss the power of simulation-guided trial design (SGTD) and explain its benefits to clinical development strategies. Whether you're a C-suite executive, clinician or statistician, this webinar is a must-see for anyone looking to unlock the power of SGTD.
Maria Lundberg discusses a holistic approach to therapeutics development and how this recently expanded team supports clients across the globe.
Interested in learning more? Complete the form below and a member of Cytel's Therapeutics Development Team will get back to you shortly.