CASES

Our commitment in clinical product development

IDRE members, advisors and associates have worked together for many years and on numerous indications and new therapies. Their accumulated experience, contacts, network and knowledge have been applied to their projects, undertaken in many fields and within an international scope. Dealing with regulatory procedures in the most relevant national regulatory organisations is an integral part of our commitment. Some examples have been summarised below.

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Somewhat driven by the global pandemic, we are rapidly witnessing the onset of an era of vast improvements in technology and treatments. The hottest trends in the 2020s will be digitalisation and automation.

IDRE has been involved in surveys to evaluate the influence of the pandemic conditions in the performance of clinical trials, CRO operations, patient access to clinical trials, alternative monitoring strategies, remote source document verification and the modification of protocols to adapt the studies to a new operational environment guarantee of GCP.

Data and all the promise hidden within is driving exponential outward expansion in the areas of expertise needed to stay relevant. “Big Data,” “Real World Evidence (RWE),” “Precision Medicine,” and others are current buzz words in the industry, however all of them require willingness to collaborate. Randomised controlled trials (RCTs) will remain the cornerstone of clinical research, but real-world data (RWD) will be become increasingly important. Volume and variety of data—such as continuous monitoring, mobile and wearable health devices, genomics, and social media—will necessitate the development and acceptance of new approaches to data and associated analyses.

Managing data volume and variety across Southern Africa, Russia, USA, EU, Brazil and several other countries, we have learnt to adapt and partner with several stakeholders that are all proving to be forerunners in the rapidly evolving “roaring 20’s”. IDRE has been operational in achieving this role while guaranteeing data integrity.

The complexity of clinical development has increased over the last few years, in part due to the higher need for specialised service providers. As a result, thanks to those services and an effective outsourcing policy, companies of all sizes have been able to increase their range of development possibilities on a global scale.

The development of the right selection policy for procurement, the selection of service providers and overseeing their work are essential nowadays for the success of a project. IDRE understands the importance of interaction between the service providers and the sponsor, budget monitoring, potential changes in scope and assessment of deliverables, while at the same time keeping these in line with project objectives and timelines.

The development of new therapies in the COVID pandemic has been a challenging enterprise involving many stakeholders, from clinical investigators to regulatory agencies, within a short time frame. Using the right resources in the design and performance of projects, from laboratory tests to clinical trials, has had to be carried out simultaneously to avoid wasting time and to allow patients quick access to the future product.

We have managed a large amount of clinical trials, laboratory tests, GMP assurance, audits and strategic advice for our clients at a global level during the long months of pandemic limitations, including COVID-19, TB and HIV.

 

Support of new innovative ideas and start-ups is one of the most important developments in the present and future treatment of diseases. On many occasions, these ideas are generated by scientists or research groups and are difficult to transform from visions into real registrable products.

IDRE develops conceptual plans driven by milestones within defined phases. Transforming a product idea into a feasible product-development plan with clear decision-making algorithms, which give the investors and stakeholders a clear view of the possibilities of the project, is the essential role played by IDRE with the support of its KOLs.

Over the past 10 years, we have seen regulatory medical writing become truly established as a profession. Many of the guidelines and processes we use are now under the spotlight as industry leaders and writing organisations try to find new and more efficient ways of working. These may include automated narrative production. The possibility of supporting small orphan disease organisations allowing them to develop international clinical projects is key to access the necessary number of cases.

One of our group companies, IDEA Regulatory, is passionate about delivering innovative products to patients with unmet needs, and they particularly enjoy putting their full weight of innovative thinking and regulatory expertise behind innovative medicine. For this reason, the company has traditionally supported orphan drugs developers allowing them to expand their clinical trial possibilities in Europe and worldwide, while at the same time supporting these companies in the execution of regulatory strategies with the main Regulatory Agencies.

Find more detailed information about the HCSTH group

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