Clinical Development and Services
We improve efficiency through our statistical design inputs and our data management, programming and writing outputs
Need for Clinical Development and Strategy Services
Despite the plethora of treatments and therapies in the market today, there is a significant need for new drugs. The clinical development program, at the heart of the long and complex process of new drug development, is its most resource intensive part.
Key Challenges
Time, quality, compliance and cost pressures continue to be a challenge, even as:
- New drug development is rapidly evolving with respect to the type of drugs & indications of interest
- The industry ecosystem is ever-changing
- The regulatory authorities are dynamically adapting to these changes
How Do We Help?
01
Efficient study designs to enable
optimal navigation of clinical and
regulatory pathways
02
Analytical and data services that lead
to robust inference and right
evidence-based decisions
03
Timely delivery of high-quality outputs
while ensuring regulatory compliance
04
Well-defined, validated metrics
to monitor efficiencies and
productivity gains
Actu-Real Clinical Development Services
Clinical Development Strategy
- An efficient strategy that Integrates requirements of multiple stakeholders
- Integrates multiple country regulatory requirements at the various phases
- Manages interdependencies and resources
Statistics and Programming
- Study design
- Statistical analysis plan
- Data standards, safety and efficacy programming
- Interim analysis, DMC
- ISS, ISE
- Submission and publication support
Data Management
- CRF and database design
- Serious adverse event reconciliation
- Discrepancy management
- Vendor data management
Clinical Writing
- Protocol, investigator brochure, ICFs
- Clinical study reports
- Clinical summaries and overviews
Medical Information and Communication
- Manuscripts, conference abstracts and presentations
- Sales and marketing material
- Product monographs
- MI query responses
The Actu-Real Advantage
Premium clinical trial support along with best-in-class statistical expertise for efficient clinical trial design
In-depth experience that spans across the pre-launch and post-launch continuum
Breadth and depth of leadership experience across clinical development phases and TAs
Customized solutions by company type, product type, and by study phase
Optimized global delivery model with 15+ global offices and delivery centers
Flexibility of engagement models: FTE-based, project-based, deliverable-based and hybrid
FAQs
Drug development is the process of bringing a new drug or device to the market and includes drug discovery, preclinical research and clinical research. The clinical research part of the development process that refers to studies conducted in people (healthy volunteers and/or patients) constitutes the clinical development phase.
Clinical development strategy is a detailed roadmap with carefully planned steps progressing through the various stages of the clinical research process. The strategy includes planned key studies and their sequence based on the objectives of the studies and the dependencies, efficient and effective study designs, plans for regulatory interactions and submissions. The clinical development strategy is based on an identified development pathway which is determined by market selection and targeted product profile and positioning for the selected markets.
Drug developers design clinical studies based on what they want to accomplish from the different clinical research phases. Clinical studies follow a typical sequence from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. Some trials have an earlier stage called Phase 0, and there are some Phase 4 trials done after a drug has been licensed. The early phase trials typically look at whether a drug is safe and study its pharmacokinetic and pharmacodynamic properties. Later phase trials aim to test the efficacy of the drug and whether a new treatment is better than existing treatments.
Statistics enables design of an efficient and effective clinical development program to allow inference about safety and efficacy of the drug in the most resource-optimized manner. Smart statistical designs can cut the time and cost of clinical development. Statistics also plays a crucial part in the process of collecting, understanding, analyzing and presenting clinical study data. Statistical programming is required to create regulatory submission-ready datasets and tables, figures, and listings (TFLs) that aid in reporting clinical study data. Statistical programmers use appropriate statistical software to perform the analysis as specified in the statistical analysis plan for the clinical trial.
Clinical Data Management (CDM) leads to generation of high-quality, reliable, and statistically sound data from clinical trials, thereby having the potential to reduce time from drug development to marketing. The scope of CDM includes designing the case report form (CRF), CRF annotation, designing the database, data capture, data validation, discrepancy management, medical coding, data extraction, locking the database and transferring/archiving the data.
Clinical writing typically includes clinical documents that are needed for regulatory submissions in order to get a drug or device approved (examples: protocol, clinical study report, clinical summaries and overviews, integrated summaries, narratives, investigator’s brochure, response to regulatory queries). Medical communication includes documents that are intended to disseminate study or drug/device data to a larger audience beyond regulatory authorities (examples: manuscripts, posters and presentations, slide decks for training or as promotional material). Other scientific writing documents may include global and local value dossiers, post-approval and RWE study documents, health technology assessment reports, health economics related documents, etc.
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