Clinnovate Consultancy

Through our parent company, Clinnovate, we use our extensive global experience in strategic drug development planning, clinical protocol development and execution to help companies design and structure their clinical trial processes to maximise their potential for success.

Clinnovate logo grey

CLINNOVATE
CONSULTANCY

Through our parent company, Clinnovate, we use our extensive global experience in strategic drug development planning, clinical protocol development and execution to help companies design and structure their clinical trial processes to maximise their potential for success.

Clinnovate logo grey

We have a passion for helping life-changing therapies make their way successfully to market.

Clinnovate works as CGX’s consultancy body, providing best practise and knowledge for your clinical research and drug development.
It is vital to get buy-in from governing bodies as early as possible in the highly regulated drug development environment. This ensures speed to market and minimises the potential for delays.

Clinnovate has a team of dedicated professionals with more than 30 years’ regulatory, clinical, and management experience, including former US Food and Drug Administration (FDA) committee members and individuals with European Medicines Association (EMA) expertise. This background in regulatory strategy and consulting makes us a strong partner for any organisation with needs in this area.

WHAT WE PROVIDE

We partner with you to develop plans that are sound from a regulatory perspective, and take into consideration your organisation’s goals. We understand current global trends in research and drug development, and we will help you develop a thorough and realistic Clinical Development Plan (CDP), designed to deliver the required regulatory feedback and set your program up for success.

Using our experience, we guide you through the complex regulatory environments, helping to ensure the right questions are posed and pertinent issues are addressed. This propels programs forward and minimises the risk of study delays and clinical holds due to unforeseen regulatory requests.

We have an integrated approach to clinical trial planning and design, and use our expertise from a diverse team of medical, regulatory and operational specialists to ensure that trials are set up for successful execution and yield data that are supportive of downstream development activities. We conduct customised global feasibility surveys as part of trial design planning to assess items such as timelines, cost and enrolment projections by region or country.

When we manage study start-up, the total start-up time is generally less than half the industry average. This includes devising global regulatory strategies for multi-national clinical trials.

We provide comprehensive protocol development services based around our extensive knowledge and experience in industry, academic and medical settings. Our therapeutic expertise, investigator relationships, knowledge of patient populations and standards of care help to deliver executable trials with minimal protocol amendments.

We continually work with you to assess timelines, look forward at upcoming milestones, maintain critical path activities, and provide overall guidance and leadership for the successful conduct of a given trial. We review budgets at regular intervals, identify future overruns early in the process, and consistently provide clear communication regarding budgets.

We measure success by using performance metrics and will provide regular updates to you on progress, potential risks and mitigations. This helps you to be proactive in anticipating and addressing any required changes, for example, to practice or administration.

We collaborate and liaise with the most experienced individuals with advanced degrees including PharmD, MD, and PhD certifications.

As part of our work with sponsors around the world, we routinely collaborate with functional departments including Medical Affairs, Regulatory, Biostatistics, and Clinical Trial Operations, in order to help ensure that regulatory documents are developed to be scientifically, methodologically and operationally sound.

We routinely prepare:

  • Investigator Brochures (IBs)
  • Protocols & Amendments
  • Integrated Summary of Safety (ISS)
  • Integrated Study of Efficacy (ISE)
  • General medical writing
  • Clinical Study Reports (CSRs)
  • Systematic literature reviews
We manage all phases of drug development from pathway design to market, as well as indication expansion strategies. We can assist you with your drug development efforts through an integrated approach that includes clinical, scientific, and marketing expertise.
We partner with you to develop plans that are sound from a regulatory perspective, and take into consideration your organisation’s goals. We understand current global trends in research and drug development, and we will help you develop a thorough and realistic Clinical Development Plan (CDP), designed to deliver the required regulatory feedback and set your program up for success. Using our experience, we guide you through the complex regulatory environments, helping to ensure the right questions are posed and pertinent issues are addressed. This propels programs forward and minimises the risk of study delays and clinical holds due to unforeseen regulatory requests.

Regulatory rigour
We partner with you to develop plans that are sound from a regulatory perspective, and take into consideration your organisation’s goals. We understand current global trends in research and drug development, and we will help you develop a thorough and realistic Clinical Development Plan (CDP), designed to deliver the required regulatory feedback and set your program up for success.

Using our experience, we guide you through the complex regulatory environments, helping to ensure the right questions are posed and pertinent issues are addressed. This propels programs forward and minimises the risk of study delays and clinical holds due to unforeseen regulatory requests.

Trial planning and design
We have an integrated approach to clinical trial planning and design, and use our expertise from a diverse team of medical, regulatory and operational specialists to ensure that trials are set up for successful execution and yield data that are supportive of downstream development activities. We conduct customised global feasibility surveys as part of trial design planning to assess items such as timelines, cost and enrolment projections by region or country.

Study development time
When we manage study start-up, the total start-up time is generally less than half the industry average. This includes devising global regulatory strategies for multi-national clinical trials.

Protocol development
We provide comprehensive protocol development services based around our extensive knowledge and experience in industry, academic and medical settings. Our therapeutic expertise, investigator relationships, knowledge of patient populations and standards of care help to deliver executable trials with minimal protocol amendments.

Project management
We continually work with you to assess timelines, look forward at upcoming milestones, maintain critical path activities, and provide overall guidance and leadership for the successful conduct of a given trial. We review budgets at regular intervals, identify future overruns early in the process, and consistently provide clear communication regarding budgets.

Performance metrics
We measure success by using performance metrics and will provide regular updates to you on progress, potential risks and mitigations. This helps you to be proactive in anticipating and addressing any required changes, for example, to practice or administration.

Practical experience
Clinnovate Consultants have many years of industry experience and broad clinical and therapeutic knowledge. Many have previous experience as clinical research associates (CRAs), nurses and study coordinators at research centres.

Some are experienced global project managers who have long-standing relationships with site personnel, which can be helpful with contract/budget negotiations and re-application of experience from previous trials. This experience helps to bring improved ramp-up times, trial delivery and regulatory approval timelines.

Specialist collaborations
We collaborate and liaise with the most experienced individuals with advanced degrees including PharmD, MD, and PhD certifications.

As part of our work with sponsors around the world, we routinely collaborate with functional departments including Medical Affairs, Regulatory, Biostatistics, and Clinical Trial Operations, in order to help ensure that regulatory documents are developed to be scientifically, methodologically and operationally sound.

We routinely prepare:

A 360-degree solution
We manage all phases of drug development from pathway design to market, as well as indication expansion strategies. We can assist you with your drug development efforts through an integrated approach that includes clinical, scientific, and marketing expertise.

CONSULTATION WITH CLINNOVATE

Book a consultation with us to find out more about how we can create a bespoke offer for your organisation.

CONSULTATION WITH CLINNOVATE

Book a consultation with us to find out more about how we can create a bespoke offer for your organisation.