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Experience

At Syntax for Science our specialized knowledge and focus on our clients’ goals sets us apart.

Therapeutic Expertise

Syntax for Science has built strategic partnerships with different companies and organizations, in order to meet the requirements of any clinical study protocol or therapeutic area.

Core Therapeutic Areas:

Oncology27%
Neurology18%
Cardiovascular & Metabolism15%
Advanced Therapies10%
Ginecology & Fertility6%
Psychiatry5%
Antiinfectives4%
Dermatology4%
Respiratory Diseases3%
Immunology & Rheumatology3%
Hematology 3%
Urology & Nephrology2%

Main Clinical Phases:

Phase I - IV TRIALS

Observational Studies

DIAGNOSTIC STUDIES

Medical Devices

Some of our Clients:

WHAT OUR CLIENTS SAY

Thank you very much for the promptness and professionalism to meet our statistical needs. We are very grateful for your excellent work and fast-solving attitude.- Head of Product Development, Diagnostic Biotech -
This company has quickly integrated state of the art DM/Stat processes (including regulatory intelligence) and started from there very directly. A fresh cost-effective and very competent DM/Stat company.- Head of Clinical Development, Oncology Biotech -
The truth is that I am very satisfied with the team for the work done with both; the electronic data capture and the statistical report. Everything was impeccable. For future studies I would not hesitate to contact you again.- Key Opinion Leader, Allergy -
It is an enormous pleasure to count with a team like yours.- Chief Scientific Officer, Cardiovascular Biotech -
The report provided was impeccable, thanks for your dedication.- Project Manager, Top 3 Spanish Pharma -

Case Studies

If you are interested to read more about our extensive experience, take some time and read our Case Studies to find out how Syntax for Science has added value to its customers.

PK ANALYSIS – Phase I

Situation

Phase I clinical trials are an essential step in the development of new drugs, establishing the recommended dose for incoming trials. The objectives of the dose escalation cohort were both assessing safety and exploring the PK profile. Non-compartmental analysis were considered per protocol.

Challenges

  • Dose Escalation Safety Committee (DESC) needs PK parameter estimations to decide the next dose.
  • The central laboratory had a delay, and provided partial data (no post-infusion concentrations).
  • Estimate parameters with limited number of post-infusion data.

SFS SolutionPK Analysis

  • Being flexible to process each patient depending on their data availability.
  • Eventually the elimination rate was calculated using infusion data fitting compartmental models.
  • Although few experimental post-infusion points were available, the AUCinf was calculated considering as 0 the BLQ observed at the next time point.

Client Advantage

The client obtained a large number of PK results, what strongly improved the knowledge of their new drug candidate.

DIAGNOSTIC TOOL

Situation

Rare diseases are difficult to diagnose due to the lack of knowledge and tools about the disease. Thus many patients are missed to diagnose and failed to be appropriately treated.

Challenges

  • Provide to the investigators an easy way to identify patients at risk.
  • Low prevalence of the disease, and long and heterogeneous natural history.
  • Disseminate knowledge about a rare disease.Diagnostic Tool

SFS Solution

  • Development of different tools based on signs and symptoms.
  • Suspicion index for general population.
  • Suspicion index for pediatric population.
  • Algorithm targeting risk subgroups.
  • The study was conducted using retrospective data.
  • Tools were developed in both electronic and paper format.

Client Advantage

The client has a training tool to provide a better knowledge about the disease, and improve an early diagnosis.

CENTRALISED ENDPOINT ADJUDICATION – Medical Device

Situation

This pivotal clinical study was designed to treat mid-face lipoatrophy. Skin thickness was measured taking ultrasound images by qualified personnel, and interpreted by a centralized blinded reader.

Challenges

  • Combine paper CRF with the centralized adjudication.
  • Evaluate images by two independent readers guaranteeing blinding along the study

SFS Solution

  • A secure web server was used to upload images and its evaluations, managing different user permissions to avoid unblinding.
  • A Quality Control procedure was implemented to minimize the variability of the independent readers
    assessments.

Client AdvantageMedical Coding CRO

  • Both paper and image data collection
    were conducted ensuring the
    blinding along the study.
  • The early quality control of the independent evaluations allowed an improvement of both assessments.

EXPERT’S EXPERIENCE SURVEY

Situation

Sponsor needs information about how the physicians are currently screening and diagnosing patients with a rare disease, and which techniques they use to assess their health.

Challenges

  • Provide an easy tool to gather information.
  • Follow-up participation and ensure response rate.

SFS Solution

  • Implement an online survey.Online Clinical Surveys CRO
  • The survey was distributed to all physicians in the Sponsors’ network by email.
  • Weekly response follow-up and
    reminders to non responders.

Client Advantage

  • A description of the physicians’ current practices were obtained effortless.

DATA MANAGEMENT LAB DATA – Phase I

Situation

Phase I studies require collecting a large amount of safety data, and conduct an exhaustive validation in order to ensure data quality. This clinical trial had two different cohorts, the first one consisted in dose escalation. The population was enrolled at one unique site.

Challenges

  • Handling a large volume of lab data.
  • Handling a large volume of queries.
  • Accomplishing tight  timing requirements in order to deliver quickly the final database.

SFS Solution

  • Conduct lab data transfers instead of entering all data into the eCRF.
  • Manage all quereis together (fired by eCRF + programmed using SAS).
  • Provide an ad hoc tool to accelerate the resolution of queries.

Client Advantage

Data collection and query resolution times wee reduced significantly, compensating the previous logistic delays. The client could proceed to start the CSR as committed to the advisory board.

Clinical Data Management

PROGNOSTIC TOOL

Situation

Prognostic estimates can be used to inform about likely outcomes of the patient’s disease. The physician can use estimates of prognosis as a guide for ordering additional tests and selecting appropriate therapies. It can also be used to define better populations for new clinical trials.

Challenges

  • Recruit enough subjects to obtain reliable results on a very specific population (bone metastasis patients with history of prostate cancer).
  • How to design a study with sensible ethical concerns.Prognostic tool

SFS Solution

  • The study was conducted using data from a biobank.
  • Discussion of the design with the sponsor and key opinion leaders provided an appropriate design which overcome the ethical concerns.

DELPHI – CONSENSUS MEETING

The Delphi method is a structured communication technique which relies on a panel of experts. The experts answer questionnaires in two or more rounds. After each round, an anonymous summary of the answers as well as the reasons they provided for their judgments is provided. During this process, experts are encouraged to revise their earlier answers. It is expected that the range of the answers will decrease converging towards the “correct” answer.Delphi Method

Challenges

  • Lack of international consensus and clear guidelines about when prescribe expensive treatment.
  • Obtain consensus among key opinion leaders.

SFS Solution

  • Obtain a consensus about how to diagnose, treat and follow up patients with a rare disease by the creation of a clinical guidance.
  • Set up a face to face meeting with the scientific committee.
  • Set up a survey

CLINICAL OPERATIONS – Phase III

Situation

The recruitment rate in a pediatric study conducted by General Practitioners (Pediatrics) in Public Institutions is always a challenge due to the overload and inexperience of the investigator team and specific population. In this study, the presence of a placebo-arm and the fact that the disease peaks seasonally, increased the difficulty of the recruitment rate.

Challenges

  • Pediatric study and Placebo arm. Vulnerable population.
  • Seasonal disorder (summer) vs.family availability (holidays). Low rate recruitment.
  • Performed by General Practitioners (Pediatrics) in Public Institutions. Inexperienced and overloaded research team.

SFS Solution

  • Study design allowed patient to withdraw the study after 4 days of treatment if no improvement.cro-full-services
  • Spain: Non-recruiting sites were promptly closed and new identified ones with high projection figures were opened.Study also opened in Mexico. Half of the recruitment reached in 8 months. A total of 54 sites were activated at the end of the study.
  • Close communication with sites, re-trainings on GCPs/protocol, monitoring timetable according to site availability (mostly afternoon).