Therapeutics Development Team
FIND Forward

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

• Support development of Clinical Study Protocols and Clinical Study Reports across most therapeutic areas, spanning Phase I — IV clinical trials.
• Support Clinical Summary Documents, such as Briefing Books and ISS/ISE document creation.
• Support annual reports (DSUR), IB updates, narrative writing, and publications.

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 

• Provide non-clinical pharmacokinetic (DMPK), toxicological scientific and regulatory support.
• Ensure compliance with regulatory requirements and regulatory standards, such as Good Laboratory Practice (GLP), and comprehensive documentation. 
• Design and timing of DMPK studies such as tissue distribution studies, metabolism (in vitro and in vivo) studies, toxico- and pharmacokinetic studies and in vitro drug-drug interaction studies.
• Design and timing of nonclinical toxicology and safety studies such as toxicity studies, genotoxic (in vitro and in vivo) studies, reproductive studies, carcinogenic studies and safety pharmacology studies.
• Support and monitoring nonclinical studies.

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

• Evaluation of data sources for suitability for SCAs.
• Strategy and trial design informed by experience submitting SCA’s to regulators.
• Target trial emulation.

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

• Pricing & market access landscape assessment. 
• Relevant pricing and performance analogs.
• Value driver assessment / SWOT / gap analyses to guide early CDP, RWE, HEOR programs.
• Input into phase 2 CDP as beta tests.
• Policy/regulatory environment landscape assessment.

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 

• Offer our proven expertise and experience in adaptive methods, Bayesian methods, and other novel clinical trial design techniques.
• Optimize the speed, savings, and probability of success of your clinical trials.

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

• Clinical Development Plan
• Endpoints and other measures selection, including biomarkers and PROs 
• Patient Population Selection, adaptive enrichment and companion diagnostic strategies 
• Trial Design and Simulations-Guided adaptive trials design  
• Statistical Support for design and execution  
• Probability of success and interim decision-making

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

• Provide regulatory strategies, roadmaps and gap analyses
• Facilitate meetings and communication with regulatory bodies
• Ensure compliance with FDA and EMA regulations and guidelines
• Regulatory project management and compilation of submissions
• Authoring of regulatory documentation
• Regulatory positioning within Target Product Profiles

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

• Provide comprehensive sponsor oversight services
• Develop a customized project management plan
• Minimize risk and optimize efficiency during CRO and vendor procurement
• Mitigate risks and ensure compliance in your development program
• Assist in preparation and coordination for regulatory submissions

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

• Procurement of CDMOs for both drug substances and drug products.
• Offering guidance on the quality standards for each specific development phase.
• Writing and compiling CMC documentation for clinical trial and registration application.
• Providing support in scientific publications, scientific advice meetings, and due diligence assessments.

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:

• Assist in the development, refinement, and evaluation of clinical pharmacology packages
• Study design, analysis and reporting
• Dose optimization
• Support drug-drug interaction (DDI, in-vitro interaction) assessments
• Population PKPD modeling and simulation
• Due diligence