Expert delivery of Adaptive Design for early phase clinical trials

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Adaptive Design for early phase clinical trials

Industry pioneers for the expert delivery of Adaptive Design for early phase clinical trials

In the last several years the interest in Adaptive Study Design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development.

Established as Europe's industry leaders and backed by the support of a highly experienced team of clinical pharmacologists, project managers, a world-class Scientific Advisory Board and a wide range of on-site therapeutically aligned experts, RPL is perfectly equipped for the conduct of complex studies requiring the application of the Adaptive model in, but not limited to; FTIH, TQT, Japanese and Bridging Studies:

Experienced: Successfully conducted adaptive protocols for over 5 years

Richmond Pharmacology (RPL) has successfully conducted adaptive protocols in Phase I-II studies for over half a decade, with a proven track record of adopting efficient strategies which allow for significant savings of cost and time.

This in turn guarantees our partners a competitive advantage by delivering the right return on investment.
Supported: MHRA and NRES supported

The UK has a favourable regulatory climate to support adaptive study design in early phase research including complex FTIH studies.

Both the Medicines and Healthcare products Regulatory Agency (MHRA); and National Research Ethics Service (NRES) support adaptive study designs and flexible protocols which allow adaptations of the study while it is ongoing, taking into account the data as it evolves.
Flexibility: Intelligent, safe and flexible

Adaptive Design is intelligent and safe ensuring the necessary flexibility to respond quickly to new information and to progress efficiently within umbrella study protocols.

Any adaptations within a flexible/adaptive study design do NOT require a protocol amendment as long as the initial protocol allows and justifies the potential for these adaptations.
Leading the way: ...In Innovations for Adaptive Design

RPL recently attended the 10th Annual Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT) where RPL's Medical Director and Co-Founder Dr Ulrike Lorch gave a presentation on "The Use of Adaptive Study Design in Early Phase Clinical Research", one of three cutting edge presentations on adaptive studies featuring Caridad Pontes from the Universitat Autònoma de Barcelona (Spain) and Filip de Ridder from Janssen (Belgium)…Read More »

Any adaptations within a flexible/adaptive study design do NOT require a protocol amendment as long as the initial protocol allows and justifies the potential for these adaptations.

Examples of which include:

Dose selection (e.g. define starting dose and maximum exposure only)
Dose selection for progression from SAD to MAD
Flexibility with up-titrations or splitting of daily doses
Optional cohorts
Flexibility with subject numbers in cohorts
Flexibility with subject numbers in sub-cohorts (staggering of dosing within cohorts)
Clinical judgment applied with stopping criteria (clinically significant drug related toxicities)
Flexibility with number of samples/measurements and time points

Want to know more? We're happy to help. Contact a member of our Business Development team today to discuss your Phase I/Phase II study requirements. With unmatched expertise you will not be disappointed...

	About Us Specialist Services First Time Into Human TQT Studies Bridging Studies Patient Recruitment Full Service Testimonials and Case Studies News Publications Contact us Work at RPL Links Latest Videos Professor Camm discusses Novel drugs, Implantable Devices & Atrial Fibrillation Burden.	home \| specialist services \| adaptive study design Adaptive Design for early phase clinical trials Industry pioneers for the expert delivery of Adaptive Design for early phase clinical trials In the last several years the interest in Adaptive Study Design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development. Established as Europe's industry leaders and backed by the support of a highly experienced team of clinical pharmacologists, project managers, a world-class Scientific Advisory Board and a wide range of on-site therapeutically aligned experts, RPL is perfectly equipped for the conduct of complex studies requiring the application of the Adaptive model in, but not limited to; FTIH, TQT, Japanese and Bridging Studies: Experienced Successfully conducted adaptive protocols for over 5 years Richmond Pharmacology (RPL) has successfully conducted adaptive protocols in Phase I-II studies for over half a decade, with a proven track record of adopting efficient strategies which allow for significant savings of cost and time. This in turn guarantees our partners a competitive advantage by delivering the right return on investment. Supported MHRA and NRES supported The UK has a favourable regulatory climate to support adaptive study design in early phase research including complex FTIH studies. Both the Medicines and Healthcare products Regulatory Agency (MHRA); and National Research Ethics Service (NRES) support adaptive study designs and flexible protocols which allow adaptations of the study while it is ongoing, taking into account the data as it evolves. Flexibility Intelligent, safe and flexible Adaptive Design is intelligent and safe ensuring the necessary flexibility to respond quickly to new information and to progress efficiently within umbrella study protocols. Any adaptations within a flexible/adaptive study design do NOT require a protocol amendment as long as the initial protocol allows and justifies the potential for these adaptations. Leading the way ...In Innovations for Adaptive Design RPL recently attended the 10th Annual Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT) where RPL's Medical Director and Co-Founder Dr Ulrike Lorch gave a presentation on "The Use of Adaptive Study Design in Early Phase Clinical Research", one of three cutting edge presentations on adaptive studies featuring Caridad Pontes from the Universitat Autònoma de Barcelona (Spain) and Filip de Ridder from Janssen (Belgium)…Read More » Any adaptations within a flexible/adaptive study design do NOT require a protocol amendment as long as the initial protocol allows and justifies the potential for these adaptations. Examples of which include: Dose selection (e.g. define starting dose and maximum exposure only) Dose selection for progression from SAD to MAD Flexibility with up-titrations or splitting of daily doses Optional cohorts Flexibility with subject numbers in cohorts Flexibility with subject numbers in sub-cohorts (staggering of dosing within cohorts) Clinical judgment applied with stopping criteria (clinically significant drug related toxicities) Flexibility with number of samples/measurements and time points *Want to know more?* We're happy to help. Contact a member of our Business Development team today to discuss your Phase I/Phase II study requirements. With unmatched expertise you will not be disappointed...
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Adaptive Design for early phase clinical trials

Successfully conducted adaptive protocols for over 5 years

MHRA and NRES supported

Intelligent, safe and flexible

...In Innovations for Adaptive Design