Asking the right questions is of utmost importance for any research, especially in clinical research to ensure a scientifically sound study design.

HEMEX’s biostatistics 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 defining analysis strategies.

HEMEX can support you in orchestrating intricate statistical methods, implementation of adaptive designs, identifying and managing missing data. We can provide you with regulatory guidance, and strategic planning for meetings with regulatory authorities around the world.

Every year, regulatory authorities request more data. For strong clinical development, it is crucial to select the right trial sites from the start. Early and thorough assessments of all study protocols and patient recruitment plans are instrumental in avoiding mistakes which may impact your product development.

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.

Choosing suitable sites for your study, locally, or around the world enables an efficient and reliable clinical development process.

Based on your regulatory, commercial and budgetary requirements, HEMEX can provide customized services around the world.

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, including vendors, and 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 RA’s.
  • Multidisciplinary coordination of amendments, assessing changes to study procedures, renegotiation of site agreements, and following up on resubmissions.
  • Building and maintaining trustworthy trial site team relationships with open communication.

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

Blinded studies are conducted to ensure the subjects and study staff report unbiased outcomes. Whilst blinding a study sounds 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 maintained by all staff members to handle the study without breaking the blind. HEMEX can support with this to ensure the study runs as smoothly as possible.

Our team can help you overcome challenging logistics by developing plans to anticipate potential problems whilst designing the study so we can enable great clinical development.

Thorough document preparation expedites the submission process and enables smooth project management.

Our study team consists of the SSUL, project manager, CRAs, biostatistician, medical monitor and logistics specialists can support you with the following documentation:

• 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
• Clinical Monitoring Plan
• Risk Management Plan
• Training Materials

We take care of the arduous process of negotiating with investigators. An appropriate compensation for your future customers ensures optimal patient recruitment, all while remaining within your budgetary constraints.

Once enrolled, we keep track of recruitment milestones and can execute payments.

In order to assure full compliance with regulatory requirements of patient indemnification in case of safety events, we offer 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. To obtain approval for your clinical study, HEMEX can help you establish a positive channel of communication with Ethics Committees and national regulatory authorities. We can compile country-specific dossiers to submit in the 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 study subjects, high-quality data collection, and that your trial remains on schedule whilst meeting key-milestones.

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

Our Clinical Research Associates (CRAs) can facilitate clinical trials irrespective the therapeutic area. They’ll bridge the gap between your company, clinical study site managers, and patients, ensuring all processes are optimized, enabling the successful completion of your trial.

We understand that each study is unique, therefore, we pay attention to every detail along the process and implement improvements where needed. Our experts are up-to-date on regulatory guidelines and technical requirements specific to your study to drive constant process improvement.

During a clinical trial, unexpected results can have a big impact on your study. Our CRAs are used to proactively adapting to all manner of situations.

At HEMEX, we consider our initial meetings to be of utmost importance.  During these early stages, we will implement communication policies and trainings, ensuring all project roles are clearly defined. We set common expectations and can then establish a project plan with milestones and timelines.

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

We take care of safety surveillance during all stages of the product life-cycle across pharmaceuticals, diagnostics, biologics, medical 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 provide safety surveillance solutions to our clients and a holistic approach starting from advice on accuracy information contained in instructions for use and inserts for drugs/device. We can support with registering on pharmacovigilance portals on your behalf in each authorized market.

Our up-to-date knowledge surrounding changing regulatory environments makes us a consistently reliable partner.

Comprehensive Clinical Data Management (CDM) is imperative for obtaining correct clinical trial results. To ensure high levels of transparency and reproducibility, accurate data-management is key. Our CDM team 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)).

Our team can help you identify the best-suited digital Data Management platform. 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 a high level of data-quality is maintained throughout, updating you with developments across all time-zones.

Effective management is imperative to the success of complex projects such as clinical trials. HEMEX can support your project throughout all phases, starting with the identification of KOLs, investigational sites, maintaining patient safety and ending with final report submission to the regulatory authorities. We can assist with schedule outlining, budget preparation, resource management, communication, task prioritization, risk assessment and mitigation, project tracking, and progress evaluation.

We can anticipate bottle necks, for instance slow recruitment rates, and build fail-safe mechanisms into our project management to keep your study running according to projected timelines. Within our close network, we have experienced vendors and experts with strong track records. Our customers can gain access directly to these services through us and maintain a single point of contact.

Sophisticated project management tools allow for traceability and transparency within the project team, and for accountability with other vested parties.

Through extensive experience in multicenter studies involving thousands of patients, we maintain close contact 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. We also understand how important TMF architecture can be to easily retrieve documents, and we always come up with practical frameworks adapted to your study.

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 privacy and security is maintain after the study.

With the right auditing strategy, you can evaluate quality and integrity of a clinical 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 study conduct. 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 multicentre 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, can continually fine-tune remote audit strategies.

You have now collected all the evidence you need to be able to answer your original clinical investigation questions. We can help you clean and analyze your data 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 Committee (IDMC), we coordinated with KOLs in our network and identify suitable experts in various fields as IDMC members.

We also support you in establishing Statistical Analysis Plans for your study that grant traceability, transparency, and accountability. Our biostatisticians 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. Our medical writers have an understanding of the regulatory requirements globally and can support you in preparing and submitting this report to the regulatory authorities.

The HEMEX medical writers capture all the necessary information from the various data sources and produce high-quality preclinical/clinical reports and safety reports. 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 your product development.

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.

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.