About us


ClinSearch is a European Health Research Organizationwhich provides Consultancy and Operational services for Medical Device and Drug Development. We offer more than quality at each step of your project, more than a highly qualified team, more than customer satisfaction… ClinSearch is committed to offer cost-effective solutions for designing and managing clinical evaluations, real-life studies or any other healthcare assessment. This is why ClinSearch is known as a company committed to results and has earned a reputation for delivering practical, measurable and high added-value data.


At ClinSearch we work to ensure that our team of highly qualified specialists in health sciences delivers the best quality results and a high level of availability to meet and exceed the needs of our customers. With this in mind ClinSearch provides outstanding solutions that are not only adapted but complete. Our aim is to help you promote your innovation in Europe’s growing market.

We do this by:

  • Building long-term customer partnerships with customers to develop new approaches in conducting Clinical Trials or Epidemiological Studies
  • Sharing our ideas to support your development plan strategies
  • Promoting cost-effective solutions in a wide range of health research services
  • Providing decision-making answers
  • Assigning resources recognised for their knowledge, innovative research techniques, insightful analysis and recommendations
  • Ensure rapid mobilization of experts networks

Working Together Results In Satisfaction!

Intelligent and innovative research

Grounded on cutting-edge scientific knowledge and mastery of best research practices.

High service quality

Through compliance with international, regulatory and industry standards and constant re-examination of our processes and policies.

Cost-effective solutions

By tailoring your project to your needs and ensuring that you get the highest added-value from it.

Highly available teams

To keep you informed and in control of your project through its whole lifetime.

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  • Safety and risk management

  • Statistical and methodological consulting

  • Clinical data management

  • Statistical analysis and reporting

  • Regulatory medical writing

  • Scientific communication / publishing

  • Project management

  • Clinical monitoring

  • Auditing

  • Post-marketing surveys

  • Occupational Health & Safety

  • Acceptability

Safety and risk management

Safety evaluation standards in the medical device world are progressively getting closer to those applicable to biopharmaceutical products. Thanks to its global knowledge and wide experience in clinical evaluation, ClinSearch can bring different services to companies by applying internal procedures in accordance with the European legislation and guidance MEDDEV 2.12-1 rev 8.

These services include:

  • Incident/Serious adverse event (SAE) reporting assistance,
  • Narrative writing,
  • Writing of initial, follow-up and final incident SAE reports,
  • Writing of periodic summary and trend reports.

Statistical and methodological consulting

Statistical and causal inference form the heart of scientific thinking in experimental sciences. They form the theoretical basis for the whole methodological corpus used in life sciences, from laboratory experimentation to large-scale epidemiological research. As such, they are a key to successful research. ClinSearch brings thorough and creative methodological thinking to your projects, from design to reporting time.

Every clinical investigation ends by the computation of a single statistical test or parameter that provides the answer to the primary study question. Performing such a test is usually trivial for any moderately skilled statistician. Ensuring that it yields a useful result, on the other hand, requires careful thinking, at study design time.

Indeed, most design choices have statistical implications: experimental design, evaluation criteria, subject selection criteria, follow-up modalities… Yet, these implications are often overlooked, leading many studies to end up underpowered, biased or otherwise hampered in their conclusions. Conversely, the choice of appropriate analytical methods requires the injection of clinical intelligence into statistical thinking.

ClinSearch consulting services integrate clinical, statistical and causal insight into your designs, especially in the following domains:

  • Controlled trials,
  • Cohorts and registries,
  • Case-control and other retrospective studies,
  • Surveys and polls,
  • Meta analysis and systematic reviews,
  • Diagnostic accuracy studies.
  • Development and validation of questionnaires, scales and indexes.

Our offer, for your new projects, includes:

  • Protocol design,
  • Statistical review of protocols and case report forms (CRFs),
  • Sample size evaluation,
  • Design and implementation of randomisation or minimisation schemes,
  • Statistical analysis planning (SAP),
  • Database design,
  • Data validation planning and programming.

Clinical data management

When it comes to clinical studies, ClinSearch closely works with selected partners specialized in Data Management that possess all the standard tools used for clinical data management including but not limited to ClinTrial, Oracle Clinical, MedDRA and WHO Drug.

At ClinSearch, the Head of Data Management is responsible for all the strategic aspects that are crucial in the clinical data management:

  1. Selection of Data Management partners by audits
  2. Contract negotiation with the selected partner
  3. Validation of the task order based on contractual aspects
  4. Quality control of the Data validation plan
  5. Quality control of the Annotated CRF
  6. Quality control of the database set up
  7. Quality control of the data entry (single or blind/interactive double data entry)
  8. Tracking of Case Report Forms (CRFs) and Data Clarification Forms (DCFs)
  9. Management of data queries sent to investigators
  10. Preparation and management of Data review
  11. Consolidation of adverse events data across the clinical and the safety database.

This Premium process meets the highest scientific and regulatory requirements. It is designed for clinical evaluations aimed at obtaining market authorisation or reimbursement.

The process may be adapted according to the nature of the missions ClinSearch is been put in charge of.

Our standards are based on:

Statistical analysis and reporting

Through mastery of both advanced statistical skills and industry standards, our team of biostatisticians is expert at turning raw data into value and delivers high quality output for a variety of needs.

  • Quality control and data validation,
  • Statistical support for data monitoring boards and blind reviews,
  • Statistical input for all kinds of regulatory documents,
  • Preparation of statistical and graphical material for scientific publishing and presentation,
  • Production of standard or custom data sets,
  • SAS programming and training services,
  • Statistical review of raw study results, regulatory documents or published materials.

Both at design and reporting time, our biostatisticians work closely with our medical writers to ensure that all produced documents are statistically accurate and complete.

Regulatory medical writing

A team of experienced medical scientists write all your documents for research, evaluation, scientific publishing and marketing authorisation application.

Study documents

We write all your study documents, from design to reporting, including: synopses, protocols, case-report forms, information and consent forms, study reports, as well as documents for regulatory applications.

Thoroughly familiar with applicable international standards and with the European regulatory framework and experienced in the whole study process. This allows us to anticipate difficulties and avoid pitfalls.

Marketing authorisation applications

We prepare your Common Technical Documents (CTD), whether those are based on original research or on bibliographic review. We especially write sections 2.5 (Clinical overview), 2.7 (Clinical summary) and module 5 (Clinical study reports).

We also prepare simplified applications, for instance for generic drugs or amendment of an existing authorisation, and Summaries of product characteristics.

Scientific communication / publishing

Scientific publishing

With our clients’ best interest in mind, we write state-of-the-art original articles or meta-analyses, complying with current reporting standards and best practice guidelines, in the fields of clinical research, epidemiology, diagnostic accuracy assessment, public health… We handle your manuscript submission operations, including replies to editors/reviewers comments, revisions and resubmission.

Our writers also prepare special journal issues, based on scientific meetings or symposia, including proof-reading, formatting and rewriting.

Scientific communication

We design and prepare all materials for written or oral communications in scientific meetings (abstracts, posters, slides, talks).

Please see also

Together, ClinSearch writers have co-authored more than two hundreds peer-reviewed scientific papers and an equivalent number of scientific communications or other works.

Please see The complete list of scientific works by ClinSearch authors.

Project management

With a strong scientific background and a long industry experience, ClinSearch project managers (PMs) focus on high quality, timely and on budget execution of your international or your local investigation project dealing with medical devices or medicines.

At ClinSearch, PM is a full service

ClinSearch PMs can rely upon an international team of clinical research associates (CRAs) and assistants of operations for the realisation of operational tasks. Beside their in-depth knowledge of operational management, our PMs are also able to provide you with advices on regulatory questions and prepare regulatory submissions files, to write scientific documents such as protocols, case report forms (CRF) or informed consent forms (ICF), to manage biostatisticians and medical writers. In this way, PMs have an overall view of the project enabling its optimal progress, respecting timelines and budget.

Communication with customers as a cornerstone of project success

ClinSearch PMs are also committed to maintaining a permanent communication channel with study sponsors so that they are kept informed and in control of their project’s progress. Meetings as well as regular project status reports can be provided in this framework.

Clinical monitoring

Providing you with the highest quality service for your clinical evaluation: obtaining data able to prove your product’s innovation

Under the responsibility of their Project Manager (PM), ClinSearch’s international team of experienced Clinical Research Associates (CRAs) has the ability to recruit, manage and monitor investigation sites across the whole European territory. While exhibiting a high level of autonomy and responsibility, our CRAs provide customers with the most accurate, complete clinical data, with proper documentation of the ongoing recruitment and follow-up process. They are especially anxious about early problem spotting and reporting so that timely corrective actions can be taken.Here is a short summary of our clinical operations services:

  • Regulatory and ethical approvals,
  • Feasibility assessment,
  • Investigator recruitment and training,
  • Investigators and steering committees meetings organisation,
  • Site management (initiation, monitoring, queries management, close-out).

ClinSearch monitoring processes are deeply rooted in industry standards, international guidelines, regulations, ethical principles and compliance (please see our Quality policy and Compliance statement). These are regularly improved with growing experience or when new valuable ideas or methods arise. Our Standard Operating Procedures (SOPs) are available on request, although we will gladly accept to work with yours, should you require it.


ClinSearch performs internal and external audits (vendors and partners) for your clinical evaluations and post-marketing surveys under the responsibility of our Regulatory Affairs/Quality Systems Manager.

Our services include:

  • Study documents audits (study protocol, CRF…),
  • Trial Master File (TMF) Audits,
  • Investigator Site File audits,
  • Database Audits,
  • Clinical Study Report Audits,
  • System Audits (Quality Management Systems, Data management, SOP compliance).

Our standards are based on:

  • ICH — Good Clinical Practice,
  • GHTF and AHWP guidance,
  • Good epidemiological practice,
  • Application of regulatory requirements,
  • ISO 9001:2015,
  • ISO 19011:2011,
  • ISO 14155:2012,
  • ISO 13485:2012,
  • ISO 14971:2013.

All audits are performed to assess the quality of study data and conduct, and ensure compliance with our above-detailed standards. These standards correspond to your study’s type (clinical trial or epidemiological study, assessing a drug or a medical device, etc…) as well as appropriate Standard Operating Procedures (SOPs) and the study protocol. According to your company’s preference, either ClinSearch’s Standard Operating Procedures (SOPs) or yours can be used.

Please see also our Quality Policy.

Post-marketing surveys

Clinical trial is the major tool to prove your innovation but post-marketing surveys (PMS) allow, under real-life conditions, to improve the knowledge on clinical and/or safety data, to establish risk management plan, and to support a long-term marketing development of your product.

PMS deal with marketed products that are prescribed in the usual manner and used in accordance with the approved label. There are no protocol-specific interventions/procedures. Therapeutic strategy, as well as decisions of management and follow-up, is strictly under the physician’s responsibility as per usual practice, and prescription is clearly separated from the decision to include the patient in the study. Moreover, epidemiological methods are used for statistical data analysis.

Which type of PMS for your study?

The study design is to be deeply discussed with our methodologists as the whole success of your project depends on it.

Here are the different types of PMS that can be proposed to you.

  • Cohort studies and registries are an irreplaceable way to document real-life performance and safety of a drug.
  • Case-control and other retrospective studies may be a great help in investigating rare adverse events.
  • Cross-sectional surveys may be used to precise the epidemiology of a condition, for instance to identify the target population of a drug.
  • Phone surveys and polls.
  • Medico-economic evaluations.
  • Post authorization safety studies (PASS): investigate the frequency of already known adverse events and possible rare adverse events not yet identified.

Our Services for your PMS:

As for clinical trials, each PMS is handled by a dedicatedproject manager who can rely on an international operational team composed of operation assistants and epidemiological research associates (ERAs) who are able to travel all over Europe for the needs of your study.

Please feel free to contact us for further information and a personalised advice.

Occupational Health & Safety

In a strong scientific environment, we offer various occupational health tools to:

  • Assess your health indicators, case-control study with a large cohort in general population
  • Prevent the emergence of new risks
  • Measure the efficiency of your prevention policies
  • Identify new prevention axes

All evaluation are done by respecting the anonymity of employees (TTP).

Our Services for OHS evaluation:


  • Methodological advice on study design,
  • Regulatory aspects related to such types of studies,
  • Protocol writing, ad-hoc questionnaires,
  • Organizing study training for OH staff, presentation of project and study procedures,
  • Audits,
  • Data monitoring (on site or remote),
  • Data management included Web site to collect survey data,
  • Statistical analysis and report,
  • Study report and other types of publications or communications.

Please feel free to contact us for further information and a personalised advice.


The design of an acceptable medicine is a critical step for ensuring treatment success. Acceptability of medicine is likely to prevent poor compliance and unlicensed used, especially in pediatric and geriatric populations.

Over the last years ClinSearch has acquired a valuable knowledge on predictive factors of acceptability, discovered and extracted from a large database of medicines’ evaluations. Based on valid, useful, and understandable information, our consulting services support you in designing a highly acceptable medicine.

Furthermore, we provide you with a relevant acceptability assessment of your medicine using our innovative ClinSearch Acceptability Score Test (CAST®).

Our data mining model uses real-life objective measures to position your medicine on the acceptability map and to characterize it by an acceptability profile: “Well accepted”, “Accepted”, “Poorly accepted” or “Not accepted”. In addition, this service provides you with standardized comparisons of great value among global market products. »


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