Our Services

Optimize your clinical projects with our expertise

Our Value

Our concepts are optimized under stringent cost and time considerations, ensuring efficiency without compromising quality.

Our FOCUS

Our focus is on simplifying complexity, eliminating hurdles by working collaboratively, and drawing from our industry insights to offer optimal solutions.

Our results

We excel in designing patient-centric global clinical trials, optimizing operational feasibility, and delivering tailored recommendations to drive innovation.

Operational Excellence

Vendor Selection & Contracting

Vendor selection, based on a high quality protocol, is key to the success of clinical trials. We can execute the Request for Proposal (RFP) process for you to ensure you find the vendors that fits your needs. We will support you in creating a contract with your vendor that is fair for both parties, which keeps the motivation of your vendors high and makes sure risks are distributed in a fair way

Risk-Based Approaches

Establishing a holistic risk and issue management approach significantly improves your chances of success in your clinical trials. We can help you incorporate these approaches such as risk based monitoring, study/project risk and issue management and quality tolerance limits (QTLs)

SOP Landscape

An effective SOP and process landscape is a basic requirement for clinical research which need to support you and your teams establish a consistent way of working. We can provide or augment your SOP and process landscape to ensure that you are compliant with the latest regulations.

Patient-Centricity

It is becoming increasingly important to keep the patient journey at the centre when planning clinical trials. These approaches need to be planned early and incorporated in the protocol to be truly effective. We can help you deploy patient centric approaches in your trials (e.g. e-Consent, Digital Health Technologies)

Clinical Excellence

Clinical Study Protocol (CSP)

The protocol is arguable the most important document in clinical research. We can optimise your protocol with a thorough clinical and operational review, ensuring a lean and pragmatic approach. This includes a thorough check of inclusion and exclusion criteria, streamlining Schedule of Activities leading to savings of time, resources and costs.

Clinical Development Plan (CDP)

We can support creation or review of CDPs, including benchmarking, competitor analysis and strategic positioning of your drug within the clinical landscape. We can help you achieve a straightforward and lean development concept which incorporates the latest industry trends while prioritizing patient-centric research.

Medical Monitoring

We can support you with setting up medical oversight for your clinical trials, which includes Quality Tolerance Limits and Estimands as well as a Medical Review Plans.

Briefing Books

We can guide you with the development of a convincing strategic narrative to present your product/ project to authorities, guide question selection and preparing a compelling company position to get the most out of your consultation with regulatory authorities.

Clinical Data Analysis

We can provide an independent reviews of available data, critical analysis, followed by the preparation of an expert statement for internal purposes or supporting you in presenting them to the external parties (in publications or to health authorities).

Preparing Submission Packages

We can facilitate creation or review of your Clinical Submission Documents including joint development of a red thread in your Clinical Overview or Summary of Safety and/ or Efficacy.

Modernizing Clinical Trials

Using modern approaches in clinical trials are quickly becoming the norm.
We can guide you in deploying these state of the art approaches.

Setting up your Decentralized Clinical Trial (DCT)

Planning a decentralized trial starts with a protocol that keeps these approaches in mind right from the start. Dedicated regulations have to be considered and vendors must be selected who are capable to deliver what they promise. The data flow must be optimized while also considering the role of the site and the investigator. We have experience in setting up such trials and can help you to select and deploy the right elements for your trials. This ensures that components that add value are included while avoiding those that add only more complexity to your trial.

Devices & electronic Clinical Outcome Assessments (eCOA)

Not every trial benfits from a DCT set up. Many would benefit from using some modern ways of collecting data instead. We can help you to assess and deploy the best solutions for your trials. Using devices in your trial might also impact the selected endpoints and require some planning well in advance. Please contact us early.

We can be responsible for your sponsor oversight with a plug and play solution -

operations in a box

Often, Biotech companies aren’t fully equipped to start with their clinical research activities and need to build basic infrastructure. Many do not intend to conduct Phase III clinical trials – they intend to license or sell after clinical proof of concept.

Building a high quality infrastructure including experts, a system landscape and an SOP landscape is expensive and can be inflexible. We offer a ready to use set-up that you can deploy as your internal operations team to execute your clinical trials.

Experts

We provide the experts you need - from a Chief Medical Officer (CMO) to plan your development to operational staff you need to fulfil your sponsor oversight

Assess Systems

As a sponsor you need to access your data, file documents in the trial master file and plan your trials. We assess the systems you need aligned to the overall operational setup

Processes

We use standardised operating procedures that allow for optimal alignment with vendors with efficient and effective oversight. We select the vendors, on-board them, create contracts and budgets and make sure the work is done in time, in budget and in high quality

Ease of Mind and Flexibility

We make sure you can focus on the science, your investors, the analyses of the data and the strategy of your development. Leave the execution to us.

Organisational Development

Organisational Structure

We can conduct a comprehensive evaluation of your organisational structure to ensure its alignment with strategic objectives.

Roles and Responsibilities

We can evaluate effectiveness and clarity of roles and responsibilities including teams and their empowerment in decision making

Processes and Workflows

We can reviewing key business processes and workflows to pinpoint bottlenecks, redundancies, and areas for improvement, while also recognizing the company's strengths.

Cultural Dynamics

We can support you in transforming/ reinforcing your organisation's culture driving employee engagement and satisfaction for greater productivity

M&A Support

Due Diligence

We conduct a thorough analysis of available clinical data followed by review or creation of clinical development scenarios, always keeping in consideration the competitive landscape, the clinical landscape and analysis of medical need and operational feasibility. We conduct due diligence of data rooms on your behalf and deliver a thorough assessment of risks and opportunities.

Preparation of R&D Section of Contract

Continuity of R&D activities during and after a merger or acquisition is of utmost importance. We support you negotiating a service agreement for R&D activities and make sure it is delivered as per expectations.