Asking the right questions is of utmost importance for any research. In clinical research, how you ask the questions is also key. Therefore, a scientifically sound study design is the cornerstone of a clinical study.

Our biostatistics Hemex team can support you with your clinical development plans and/or individual study protocols. This includes aspects such as study design, sample size calculations, outlining objectives, endpoints and even analysis strategies.

Hemex can support you with intricate statistical methodology. Alongside this comes any implementation of adaptive designs, identifying and managing any missing data. We can assist and give you regulatory guidance, create strategic plans for meetings with any regulatory authorities around the world and be there alongside you every step of the way.

For strong clinical development it is key to select the right trial sites from the start. The amount of clinical data requested by the regulatory authorities is increasing year on year. Early and thorough assessments of all study protocols and patient recruitment plans are instrumental in avoiding any mistakes which may impact the development of your product.

To ensure your clinical development runs smoothly, we ensure that any Pre-Study Site Selection Visits (PSSV) are performed to the highest standards. We use an evidence-based approach to ensure the site has a strong track record and good patient access.

Spending time initially to ensure the right sites are selected for your study locally or around the world ensures efficient and reliable clinical development.

Thanks to our global presence, we can provide customized services in any region across the globe based on your regulatory and commercial requirements and budget.

At the beginning of the project, a Site Start Up Lead (SSUL) will be assigned to your study to oversee all aspects of SSU and regulatory operations, including Ethics Committee (EC)/Independent Review Board (IRB) and Regulatory Authority (RA) submissions.

The SSUL is responsible for:

• clear communication and effective planning with multiple stakeholders at clinical trial sites, vendors, as well as the Sponsor.
• developing, implementing, and monitoring a SSU strategy with defined study milestones and deliverables.
• regulatory activities at a country, central and local level with ECs, IRBs, and RAs
• multidisciplinary coordination of amendments, assessing changes to study procedures, renegotiation of site agreements, following up on resubmissions.
• building and maintaining trustworthy trial site team relationships with open communication lines

This Single Point of Contact (SPoC) approach will result in getting sites started up as quickly as possible and enrolling patients according to plan, thereby reducing the overall project duration and cost.

Blinded studies are often carried out when studies are assessing subjective outcomes to ensure the study subjects and study staff report outcomes with no bias. Whilst blinding a study sounds fairly straight forward, it can be challenging to implement and subsequently manage.

Communication with physicians and the research team is critical to maintain blinding. Good communication will ensure confidence is maintain by all staff members to handle the study without breaking the blind and we can support with this to ensure the study runs as smoothly as possible.

Our Hemex team can help you overcome any challenging logistics by developing plans in advance to anticipate any problems whilst designing the study so that together we can ensure great clinical development.

Thorough documentation is another key element to keep your clinical project on track. Flawless documentation expedites the submission process and makes the project management smooth.

Our study team consisting of the SSUL, project manager, CRAs, biostatistician, medical monitor and logistics specialists will develop and update several documents:

• Protocols and amendment
• Patient information and informed consent in multiple (lay) languages.
• (e)CRF
• Investigational Medicinal Product Dossier
• Investigator’s Brochure / Instructions for Use
• Communication plan
• Data management plan
• Monitoring plan
• Risk Management Plan
• Training materials

We take care of the arduous process of negotiation investigator and (if applicable) trial subject compensations. An appropriate compensation of your future customers ensures optimal patient recruitment, all while remaining within your budgetary constraints.

Once enrolling, we keep track of recruitment milestones and execute payments in multiple regions of the globe.

In order to assure full compliance with regulatory requirements of patient indemnification in case of safety events, we bring trial insurance in place through world-renowned insurance companies with whom we have agreed attractive rates.

Clinical Trial Application is an essential practical milestone for any clinical study. Hence, to get approval for your clinical study, we can help you establish a positive channel of communication with ethics committees and national regulatory authorities. We can help you compile country-specific dossiers and submit in EU, as well as for other crucial regional authorities like FDA.

• Primary submission with strategic guidance to minimize subsequent queries
• Coordinating multi site/nation submissions
• Responding to queries
• Interaction with Ethics Committees/Institutional Review Board and Regulatory Authorities

Efficient monitoring of clinical trials ensures the safety of the study subjects, high-quality of the data, and that the project stays on track. Our experienced monitors pay attention to all the details to anticipate and prevent pitfalls, while working towards the successful conduct of the clinical trial.

• Initiation and training
• Logistics
• Routine on-site and remote monitoring
• Safety/medical monitoring

No matter the nature of your study and what scientific field it covers, we have the expert Clinical Research Associates (CRAs) in our team, that will help you complete your trial effortless and successfully. Acting as the connection point between your company, the clinical study site managers and patients, we aim to keep processes optimized and up to speed at any time.

We understand that each study is unique and should be treated as such. We will therefore pay attention to every single detail along the process and implement improvements where needed by carefully analyzing the data and implementing an efficient work distribution according to everyone’s abilities. Our experts are constantly up-to-date regarding guidelines, technical requirements and the current state of the technologies specific to your study. That way issues can be resolved before you even realize they exist and enable constant process improvement.

During a clinical trial, unexpected results can have a big impact on your study setting. Our CRAs are used to adapt to all kinds of situations in a flexible and productive way. So do not worry if your study takes some unexpected side turns, we will handle this together and straighten it out.

However, our goal is to create quality and effectiveness by default. To be able to do so, we consider our initial meetings of utmost importance. We believe that a personal understanding and agreement on procedures is crucial for our cooperation to work and create the positive spirit needed. In these first steps we will further implement communication policies and trainings so that each and every person involved in this project will have his set role. We want to settle on common expectations and have an integral understanding of how you and your team work best. Based on this knowledge we can then establish a project plan with milestones and timelines to achieve these. It goes without saying that this plan is a constantly evolving product that grows with your inputs and our expertise. 

Our safety and pharmacovigilance experts can support with industry-specific safety surveillance during product development and post-marketing internationally. With years of experience in the field, we have the insight to offer a package customized to your product and to your needs.

We take care of safety surveillance at all stages of the product life-cycle across pharma and biologics, devices, and digital app sectors. We support our customers with:

Clinical trial safety: safety monitoring for Phase I-IV studies, clinical evaluation, performance evaluation along with

• Reporting to ethics committees/Institutional Review Boards and applicable Regulatory Authorities,
• Appropriate coding of AEs and SAEs,
• Development Safety Update Report (DSUR),
• Periodic Safety Update Report (PSUR),

Post Market Surveillance plan including

• Post Market Clinical Follow-up
• Post Market Performance Follow-up
• Drug safety and pharmacovigilance

We yearn to provide one-stop safety surveillance solutions to our clients, hence we provide a holistic approach starting from advice on accuracy information contained in instructions for use and inserts for drugs/device to registering on pharmacovigilance portals in each authorized market on behalf of our clients.

Our attention to constantly changing regulatory space across the globe makes us a consistently reliable partner for our clients, and we continue to develop long-lasting partnerships backed by our credibility.

All the information that comes out of a clinical trial is directly influenced by Clinical Data Management (CDM), hence to make sure that the results of the study are transparent and reproducible, accurate data management is the key. With our CDM team we can:

• Identify and define data management elements in the study protocol,
• Lay down the Data Management Plan for the study,
• Build and annotate paper or electronic Case Report Forms (CRF),
• Identify suitable database,
• Perform user acceptability testing,
• Train the personnel involved in data capture,
• Perform quality control and assurance,
• Perform data cleaning, coding, and export,
• Perform database lock and archiving
• Prepare datasets and metadata in desired formats for regulatory submissions (e.g., Clinical Data Interchange Standards (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)).

Over the last few years, we have worked with several digital platforms involved in CDM, and we can provide insights in picking the most suitable tools for your study. We always test our CDM practices against applicable regulatory requirements. We identify the necessities according to the nature of the study, adapted for the investigational product and the Sponsor, across several regulatory settings. We ensure that the high-quality of data is maintained throughout the study and keep our customers up to date with developments across all time-zones.

For a complex project like a clinical trial, effective management is at the center of its success. With patient safety our primary goal, our multi-disciplinary team coordinates and communicates with all stakeholders of the study, and make sure that the several plans established in preparation of the project are followed with dedication and discipline. Starting from identifying KOLs and investigational sites and ending with final report submission to authorities, we support our customers with outlining schedule, budget, resource management, communication, task prioritization, risk assessment and mitigation, project tracking, and progress evaluation.

We anticipate critical bottle necks, for instance slow recruitment rates, and build fail-safe mechanisms into our project management to keep the study running according to projected timelines. Through our vast network, we bring in experienced vendors and experts with track record of several successful clinical studies, while our customers get a single point of contact through us.

We use digital tools to manage our projects, which allows for traceability and transparency within the project team, and for accountability with other vested parties. We work around the clock to iron out all the details to see a project to a rewarding conclusion.

A Trial Master File (TMF) isn’t just a regulatory requirement, it is a chronicle of the study conducted and we understand the intricate complexities involved in maintaining a TMF. Through extensive experience in multicenter studies involving thousands of patients, we harmonize between study partners and make sure that the TMF remains up-to-date. We meticulously trace the documents and file those in the living repository ensuring the robustness of the data collected is maintained. We also understand how important TMF architecture can be to easily retrieve documents, and we always come up with practical frameworks adapted for the study.

We have mastered document management through managing multinational clinical trials, which only got better with electronic TMF (eTMF) systems. Hence, on a need-based approach, we can customize a paper-based framework, an electronic TMF structure, or a seamless combination of the two.

We can also support Sponsors in archiving the TMFs and Investigator Site Files (ISFs) making sure that the privacy and security values maintained during the study are sustained.

With the right auditing strategy, you can evaluate quality and integrity of a clinical study and make sure they are upheld throughout the study.

We don’t just focus on compliance with standards and regulations during our independent GxP audits; we strive to work with our customers to improve the efficiency of the conduct of the study. By doing so, we ensure our customers and the investigational sites are prepared for inspections by authorities.

We can support Sponsor Companies with a single audit or provide on demand co-monitoring solutions starting with establishing an audit plan across multicenter studies. Our trained auditors and in-house project managers coordinate with all the stakeholders in a study and ensure adherence to the audit plan.

We recognize the imminent need for remote audits, and based on our experiences, we continually fine-tune our remote review and audit strategies.

You have all the evidence you need in your hands; you only need to uncover what it says and answer all the questions that you started with. We can help you clean and analyze the data to obtain the outcomes of the study so that you can decode the multifaceted knowledgebase collected.

Our biostatisticians work with the clinical trial management team from the beginning and incorporate Good Statistical Practices within study design and protocol which is then captured in the eCRFs. Whenever a study requires an Independent Data Monitoring Committees (IDMCs), we coordinated with KOLs in our network and identify suitable experts in various fields as IDMC members.

We also support our customers in establishing Statistical Analysis Plans for the study that grant traceability, transparency, and accountability. Our biostatisticians also provide input in study report writing to ensure the results from the study are correctly represented and interpreted.

A clinical study report is a critical part of any Marketing Authorization Application. The clinical development journey culminates in presenting a comprehensive report to the regulatory authorities with the evidence gathered. Our medical writers, with an understanding of the regulatory requirements globally, can support you in preparing and submitting this report to the regulatory authorities.

Our medical writers capture all the necessary information from the various data sources and produce high-quality reports, ranging from preclinical to clinical to safety report writing. Our medical writers also collaborate with the communications department to appropriately represent the product in desired markets for commercialization. We can customize our medical writing services as stand-alone document writing or a full range of writing services throughout the various life cycle stages of the any product.

With our knowledge of global regulatory publishing trends and submission formats (electronic Common Technical Document (CTD)/non-eCTD electronic submissions), we support compliant dossier compilation, and multinational submissions and filing throughout the lifecycle of a product.

Our experienced team works around the clock to facilitate real-time readiness across all time-zones for a quick turnaround time. We develop and compile high-quality submission-ready documents in a secure electronic platform.