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Sourcing Inquiry Logo Algorithme Pharma

Algorithme Pharma

Regions
North America
Countries
Canada
Size
250-500
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Generics
Service category
Clinical development and testing, clinical CRO, Analytical laboratory and testing services, …
Service category
Clinical development and testing, clinical CRO, Analytical laboratory and testing services, Regulatory services - CMC writing - medical writing
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Key services

Services

Phase I/IIa

With over 30 years’ safe and compliant track record, we are well positioned to support your drug development needs. Our units are led by professionals with solid expertise in early phase clinical services working closely with highly experienced project management, medical investigators and clinical teams. Our team of experts can help you design and conduct your study successfully through the following services:

 

Recruitment

Recruiting is crucial to the clinical trials process. Our effective approach to recruitment is two-fold. It includes an ongoing general awareness media campaign as well as study specific recruitment strategies to ensure that our panels are filled as quickly and efficiently as possible.

Finding and engaging targeted participants and/or patients is all about speed, efficiency, responsiveness and cost-effectiveness. The success of our recruitment programmes are in large part based on:

  • Call centres in Montreal (Canada) and Merthyr Tydfil (UK), which are open accessible hours and accommodate the varied schedules of our target audience (including evenings and weekends);
  • The talent and experience of the staff of those call centres;
  • An enrolment process that follows inclusion and exclusion criteria specifically identified in the study protocol, which boosts enrolment efficiency;
  • A solid database of more than 100,000 participants, including pre-screened patients suffering from specific illnesses;
  • An extensive network of specialist doctors allowing us easier access to target patient populations;
  • A cost-effective media plan including traditional media, online media and direct-to-participant/patient marketing;
  • Advertisement of trials on participant/patient portals.

Having the right participants is critical for a successful clinical trial. We take many opportunities to communicate this to participants and recognise them for their active part in bringing medicines to the market.

Effective participant and patient recruitment and enrolment strategies are crucial to your drug development timelines. Investment in accelerated participant and patient recruitment yields time to market savings, often resulting in a several-fold return on investment.

 

Clinic Over 30 Years Safe and Compliant Track Record in Phase I Project Delivery

Our experience and expertise allows us to offer a cost effective and flexible service. We provide a tailored service, adapting to the Sponsor’s requirements and priorities in the context of established regulatory, medical and scientific frameworks. We also provide the clinical pharmacology, scientific and clinical expertise required for a functional and successful delivery of study objectives and research questions.

We have vast experience in:

  • First in Human (including High Risk IMPs-Investigational Medicinal Products)/Safety Reviews
  • Dose escalation – single, multiple and combined
  • Clinical pharmacology (drug-drug interactions, food effect, etc.)
  • Radiolabelled
  • Scintigraphy (lung deposition, GI studies)
  • Long-stay
  • PK/PD
  • Biomarker/Pharmacodynamic models (including experimental pain models)
  • Cardiology, tQTc
  • Bioequivalence/absolute bioavailability
  • Dermatology (including skin biopsy)
  • Ophthalmology
  • Medical devices
  • Customised designs/research projects

Our units are led by a Medical Director/Investigator with over 15 years experience and expertise in early phase clinical services working closely with highly experienced project management, medical investigators and clinical teams.

Our European units have been successfully inspected by MHRA-GMPMHRA-GLPMHRA-GCPMHRA-Supplementary Accreditation Phase I, US FDA, UK Clinical Pathology Accreditation and Member of CCRA.

Our Montreal facilities have been successfully audited by the US FDA, Health Canada TPD, Brazil ANVISA, France AFSSAPS, UK MHRA and Austria AGES regulatory authorities.

Risk analysis, evaluation and management of trial participants, and regulatory and sponsor projects are central to the way we work and deliver.

Medical Emergency procedures are established, documented, regularly tested and supported by the appropriate number of personnel, qualifications, training, relevant experience, facilities, drugs, equipment and written agreements for transfer and referral to the specialist Medical Emergency Services.

 

Data management

Our team has extensive data management expertise. The quality and integrity of clinical data is a key priority for the clinical data management department. To this end, our systems are governed by well definedSOPs and are compliant with regulatory requirements such as ICH/GCP and FDA 21 CFR Part 11.

Data is entered directly into an electronic database. The study database setup is guided by the Annotated CRF. When the database has been created, a Data Validation Plan and Edit Check specification document is written that contains all checks for the study, both electronic and manual. Electronic checks are programmed to either pop-up during data entry or they will be run in separate batches during the validation. When the cleaning process is finished, a quality control check is performed on the database after which the database is audited and locked – ready for statistical analysis.

Our data management team services and procedures are as follows:

  • Detailed data management planning
  • Medical coding (MedDRA, WHO Drug Dictionary Enhanced)
  • Double independent data entry and comprehensive validation
  • Database transfer to sponsor in different formats (SAS®, etc.)

Project management

High quality project management is key to the success of a clinical trial.

Our experienced project management team has extensive expertise in managing clinical trials across a wide range of therapeutic areas and utilising numerous different study designs.

We understand the unique aspects involved in early phase drug development. Our project managers are responsive and will provide you with all the immediate and longer term support that you need. A dedicated manager will be assigned at the outset of your project and will remain your primary point of contact throughout the project lifetime.

We also recognise the importance of excellent communication. To this end, the project manager leads the clinical trial team and works closely with key departments, external contractors and the sponsor to ensure seamless and timely communication and successful completion of the project.

Our project managers are highly skilled at identifying and prioritising risks and we have established processes in place.
Site Management

In addition to management of clinical trials conducted at our European Clinical Trials Unit, we have the capabilities and experience to manage trials conducted at external sites.

If you are looking to outsource monitoring for your trial, we have access to local independent CRAs.

 

Scientific Affairs

As a full service Contract Research Organisation, we offer vast experience in the management of early phase clinical trials across a broad range of therapeutic areas.

We have a highly experienced scientific affairs team who is ready to advise and help you with your request.

We have over 35 years experience at Simbec. Our broad expertise includes the following areas:

Phase I studies:

  • New Chemical Entity (NCE) and First into Man (FIM) safety and tolerance studies
  • Food effect, gender effect, age effect, patient studies
  • Bioequivalence and comparative bioavailability studies
  • Biological/Biosimilar
  • Drug Interaction studies
  • Mass Balance/ADME Clinical Studies (C14 studies)
  • Scintigraphics studies (g)
  • Modified release formulations
  • Transdermal drug delivery
  • Inhaled drugs
  • PD profiling of pharmacological effects (biomarkers)

Phase II/III studies

  • Allergy
  • Anti-infective
  • Cardiovascular
  • Gastrointestinal
  • Anti-inflammatory
  • Oncology
  • Ophthalmology
  • Respiratory

Regulatory Affairs

We have a well established regulatory team providing a full range of regulatory services. Our experienced team works within regulatory requirements consistently producing high quality submissions.

We recognise the importance of staying up-to-date with new regulations and guidelines to ensure we give you the best possible advice.

We have immediate access to key areas of expertise such as Medical, Statistics, Pharmacy / GMP, Project Management, and Bioanalytical and Quality Assurance, and we work closely with our sponsors to ensure that regulatory submissions are produced on time, ensuring key clinical trial milestones are met.

Our range of regulatory services includes:

  • Regulatory input on protocols
  • Investigator Brochures
  • Applications for clinical trial approvals
  • Sample IMP Labels for submissions
  • Investigational Medicinal Products (IMPDs)
  • Ethics, R&D and Regulatory submissions
  • Maintenance of Submissions (Amendments) and End of Trial Reporting (End of Trial Declarations, Safety Reporting)
  • Pharmacovigilance
  • Notification of serious breaches of GCP or the protocol
  • Medical Device submissions
  • Administration of Radioactive Substances Advisory Committee (ARSAC) applications for certificate to administer radiopharmaceuticals

Bioanalytical Services

The Bioanalytical Services Department offers scientific excellence, uncompromised quality and unbeatable timelines to meet and exceed client needs.

Our GLP-compliant bioanalytical Canadian facility, located in Laval (Quebec, Canada), is 20,000 sq feet (1850 sq metres), with 24 LC-MS/MS systems (19 API3000 & 5 API5000 operating 24/7), 5 LC-MS, 9 UV detectors and 5 fluorescence detectors. It is fully equipped with a dedicated method development group and multiple state-of-the-art equipment, ensuring a straightforward and compliant submission for any country.

Simbec Laboratories are located in Merthyr Tydfil, Wales, UK and have been providing bioanalytical support for nearly 35 years. Our GLP-compliant bioanalytical UK facility is 10,000 sq feet (925 sq metres), with 5 LC-MS/MS instruments and 2 LC-MS instruments in operation as well as GC-MS.

Biomarker assays using enzyme- (ELISA) and radioimmunoassay (RIA) techniques are also an increasingly important area of work. We have a Radioisotopes laboratory which performs radioactivity measurements for human ADME and Mass Balance studies. Radio-HPLC and MS-MS techniques are used to investigate metabolite profiles and to assist the identification of putative metabolites.

Combined, our bioanalytical facilities share more than 500 validated methods for drugs, metabolites and biomarkers in biological matrices, covering most therapeutic areas.

Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:

  • Extremely low LLOQ
  • Large dynamic ranges
  • Analysis of multiple metabolites
  • Analysis from various matrices and species
  • Quick method development of high throughput assays using strict criteria
  • Successful method transfer or adaptation

We are also working on methods using new and/or high throughput technologies, such as Dried Blood Spots (DBS) analysis. Through our expertise we can overcome challenges like potential stability issues and matrix effects. One of our major focuses is to develop rugged methods that are free of interference from metabolites.

We perform assays on almost 400,000 samples per year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects (from preclinical to Phase I-IV).

 

Statistical Services

Our team has extensive experience in providing a wide range ofstatistical services.

These statistical services include the key processes outlined below.
STUDY DESIGN

The study design process covers elements such as sample size calculation, endpoint definitions and statistical methodology. Discussion of these elements occurs within the clinical project team at the earliest possible stage of protocol development.
STATISTICAL ANALYSIS PLANS

Statistical analysis plans are produced during the clinical phase and include patient populations, parameters for analysis and primary and secondary endpoints. In addition all statistical methodology is incorporated into the statistical analysis plan from the protocol.
CLINICAL DATA REVIEW

A full data review is carried out by our clinical team of doctors, statisticians and project managers. Primary efficacy parameters and standard safety data are reviewed during this process. Subject populations are also drawn up, along with listings of protocol violators.
PROJECT PROGRAMMING AND DATA TABULATIONS

Standard and study specific safety and efficacy tabulations are designed and programmed well in advance of database lock. This ensures preliminary results are reported to the client within days of randomisation code release. Data summaries are in-line with ICH requirements outlined in E3, structure and content of clinical study reports.
STATISTICAL ANALYSES AND REPORTING

The quality controlled statistical analyses are prepared by our statisticians. The collation of the protocol, statistical analysis, data listings and summary tables are prepared by our report writers with advice from our statisticians and doctors. Finally, our internal independent reviewers ensure the draft and final reports are produced to the highest possible standards.

 

Medical Writing

We have developed a strong reputation for delivering a high quality, reliable and responsive medical writing service.

Our dedicated team of professional medical writers provides a complete writing service to clients around the globe, from the generation of individual documents to extensive medical writing programmes.

You can rely on our experts to prepare, research, edit or proof copy for a wide range of documents required for the smooth running of your trial, including:

  • Protocols
  • Protocol amendments
  • Investigator Brochures
  • Investigational Medicinal Product Dossiers
  • Clinical study reports
  • Pharmacokinetic reports
  • Safety reports
  • Any other type of document necessary for a successful clinical trial.

We can also offer general medical communications such as publications, posters, abstracts, and promotional and educational material.

All documents are tailored to your individual requirements and produced to the applicable regulatory guidelines.

The medical writing team works closely with key operational departments – Medical, Clinical, Pharmacy and Regulatory Affairs, Statistics and Data Management, Project Management, Quality Assurance and Bioanalytical in order to access a fully-integrated network of expertise as appropriate for your project.

Whatever your medical writing needs, we have the right team to deliver the quality and timeliness to ensure your programme stays on track.

 

Pharmacokinetics and Pharmacodynamics Clinical Pharmacokinetics and Pharmacodynamics

Our team provides extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in pre-clinical and clinical studies. All our services are conducted in accordance with FDA, Health Canada, EMA, andICH guidelines and client requests (including the possibility of obtaining interim results).

We strictly adhere to industry standards for pharmacokinetic analysis.

Our pharmacokinetic team is both GCP and GLP compliant and provides expert services in the following areas:

  • Pre-clinical PK calculations (GLP compliant)
  • PK/PD Modelling and simulation
  • Non-compartmental and compartmental analysis
  • Development of a specific PK/PD analysis plan on request
  • Statistical analysis and Interpretation of PK and PD outcomes
  • Production of standalone PK/PD report
  • Dose Escalation decisions/review (rapid turnaround in PK analysis)
  • PK/PD input into the protocol design and Clinical Study Report

Pharmacy

The Simbec Pharmacy is fully GMP and GCP compliant.

Inspections and Accreditations:

  • Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA No 4757)
  • MHRA GMP Inspections 2004, 2006, 2008 & 2011
  • GMP Certificate (Aug 2008)

We have the capability to work with many different and novel formulations, including preparation of placebo for blinding compliance. We manufacture IMP onsite and release direct to clinic (including short shelf life products).

Our pharmacy is responsible for:

  • Blinded and dose escalation studies
  • Microdosing studies
  • Primary and Secondary packaging (e.g. tablets, capsules, inhalers etc)
  • Blinded Randomisation code generation
  • Annex 13 Compliant IMP Label design
  • Manufacture or procurement of NIMPs (e.g. challenge agents)
  • Importation of IMP from Third Countries
  • Quality Control Release Testing (via Contract Laboratory)

Our highly trained staff includes four Qualified Persons who offer covers:

  • Expertise in formulation/CMC advice
  • Regulatory advice e.g. IMPD preparation
  • Audit of Third Country Sites, GMP Declarations and Certification of IMP upon importation

Our state-of-the-art pharmacy facilities include:

  • Grade A Type I Positive Pressure Isolator and HLF cabinet for sterile production
  • Grade C Production Area
  • GCP/GMP compliant segregated material storage
  • Controlled ambient temperature in Production and Storage areas
  • Controlled Refrigerated (2 to 8ºC) and Frozen (-15 to -25ºC) storage
  • Continuous temperature monitoring & alarm system

Simbec is fully compliant with all Controlled Drugs requirements, with a full range of Home Office licenses and suitable storage/record keeping.

 

Bioequivalence

As a major global player in early stage Clinical Research and Bioanalysis, we provide a wide range of services for bioequivalence and bioavailability studies to the generic industry. Our success stems in large part from the knowledge and commitment of our team to deliver.

505(b)(2)-Generic Hybrid

Development of new or different formulations for known drugs is now a very interesting asset in R&D and clinical research. Drug products being submitted under section 505(b)(2), sharing similarities with both the 505(b)(1)-NDA and 505(j)-ANDA, have gained in popularity with recent submissions of 505(b)(2) representing over 50% of FDA’s new drug approvals.

 

Bioanalysis

Our Bioanalytical Services Department offers scientific excellence, uncompromised quality and unbeatable timelines to meet and exceed client needs.

Our GLP-compliant bioanalytical Canadian facility is 20,000 sq feet (1850 sq metres), with 24 LC-MS/MS systems (19 API3000 & 5 API5000 operating 24/7), 5 LC-MS, 9 UV detectors and 5 fluorescence detectors. It is fully equipped with a dedicated method development group and multiple state-of-the-art resources, ensuring a straightforward and compliant submission for any country.
BIOANALYSIS – From Method Development to Bioanalytical results

Our wealth of bioanalytic experience has been gained across different matrices, including plasma, serum, whole blood, urine, cerebro-spinal fluid, tissues and faeces. We also have experience in multi-sites studies, complex sample receipt and identification, concomitant medications, communication with external sites and more. Our highly trained employees are governed by and fully adhere to the highest quality standards including GLP (Good Lab Practices) and international regulations.

The Bioanalytical Services Department size allows us to quickly scale for flexibility and expedited validation and sample analysis, all while maintaining our rigorous Quality Assurance processes.

We are proud of our accurate and reliable results. Our batch & Incurred Sample Reanalysis (ISR) success rate is excellent (95%-100%), which attests to our high standards and uncompromising quest for consistent perfection in our lab work.

Our GLP-compliant bioanalytical UK facility is 10,000 sq feet (925 sq metres), with 5 LC-MS/MS instruments and 2 LC-MS instruments in operation as well as GC-MS.

Biomarker assays using enzyme- (ELISA) and radioimmunoassay (RIA) techniques are also an increasingly important area of work. We have a Radioisotopes laboratory which performs radioactivity measurements for human ADME and Mass Balance studies. Radio-HPLC and MS-MS techniques are used to investigate metabolite profiles and to assist the identification of putative metabolites.

Combined, our bioanalytical facilities share more than 500 validated methods for drugs, metabolites and biomarkers in biological matrices, covering most therapeutic areas.
Close relationship with clients

Our team maintains a strong relationship-focused approach. Maintaining good communication and a close relationship with our clients are paramount to us.

We provide regular updates from the scientist assigned to your project during method development. We also facilitate meetings, teleconferences or videoconferences to discuss our procedures and testing, if required. If desired, a specific team is designated for all your studies, and you will have direct communication with the team manager for accurate, timely information.

 

Method Development Strategy

The method development team consists of dedicated scientists with 150+ years of combined experience in the bioanalytical and method development fields. Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:

  • Extremely low LLOQ
  • Low sample volume
  • Large dynamic ranges
  • Analysis of multiple metabolites
  • Analysis from various matrices (plasma, serum, CSF, blood, urine, etc.)
  • Quick method development for high throughput assays using strict criteria
  • Successful method transfer or adaptations

Technologies

We are working on methods using new and/or high throughput technologies, such as the Dried Blood Spot analysis (DBS). We are currently performing extensive work on DBS technology and have performed comparison work to determine the correlation between plasma and DBS results during a clinical study.

Our expertise enables us to overcome challenges like potential stability issues and matrix effects. We have performed extensive work on the removal of phospholipids from plasma during solid-phase and liquid-liquid extraction. The presence of the phospholipids is one of the frequent causes of matrix effect observed in bioanalysis.
Metabolites

One area of focus is to develop methods that are free of interference from metabolites. All molecules and potentially unstable metabolites such as glucuronides, sulfates and lactones are tested whenever possible using authentic reference standards. With the reference standard, multiple evaluations, including all stability evaluations, are performed to prove the absence of ex-vivo and in-vitro conversion. Also, we have developed multiple approaches to avoid interference from labile metabolites, especially for the mass spectrometer in-source and/or interface conversion of glucuronide metabolites. Techniques such as the utilisation of adduct ions for analyte monitoring or use of different ionisation modes are employed to avoid such interference.

 

Non-GLP Studies

If your study requires non-GLP or discovery work, the Bioanalytical Services Department has in place all necessary procedures to perform these analyses within fast timelines. Once a method is developed and ready for validation and/or sample analysis, a special team is dedicated to your non-GLP work. All work is conducted following a validation plan and/or a bioanalytical plan that is written by Algorithme Pharma and accepted by the sponsor. The plan is adapted to suit all your study’s special needs.

 

Preclinical Studies

For your preclinical studies, you need a partner that provides strong bioanalytical support. The Bioanalytical services department at Algorithme Pharma has years of experience in innovative method development including complex molecule and metabolite testing using animal studies. Our strength is our partnership with clients. A direct relationship is established at the inception of method development, with the scientist responsible for the method, and continues throughout the process.

If you like, your pre-clinical methods can be transferred from sponsor laboratories, and feasibility studies can be performed to confirm suitability of the method. Also, utilisation of Dried Blood Spot analysis (DBS) is an interesting alternative for all the preclinical work to reduce the sample volume required for analysis.

One of our main focuses during method development is to have methods that are free of interference from metabolites. In collaboration with our sponsors, we perform a thorough literature research and review of the investigator brochure to determine the presence of potentially unstable metabolites. If no information on metabolites is available at the pre-clinical stage, investigation with the animal samples will be done to determine the presence of suspected metabolites. Our goal with this procedure is to ensure that our reported results are not biased by the presence of a metabolite that could convert to the analyte of interest. Also, whenever possible, the metabolite testing is performed using authentic reference standards.

Once a method is ready for validation and sample analysis, a special team is dedicated to the pre-clinical work in order to continue the relationship established during method development. All work is conducted in compliance with GLP standards and current regulatory guidelines. If required, our standards can be modified to suit your needs.

 

Dried Blood Spot Analysis (DBS)

Algorithme Pharma has added Dried Blood Spot (DBS) Analysis to its bioanalysis services. DBS is gaining recognition as a superior alternative to traditional plasma collection in many research applications because it eliminates many costly, time-consuming and unpleasant aspects of sample collection while returning excellent analytical results. By using DBS, sample collection and processing is simplified, resulting in lower collection volumes, lower sample transportation costs and easier sample storage requirements. It is also safer to handle.

These are all excellent reasons to choose Dried Blood Spot analysis whenever possible for all your pre-clinical and clinical needs. We are prepared to use our experience with this technique to develop a robust and reliable method for your study. Research performed by the Method Development group has proven that methods using Dried Blood Spots are just as reliable as methods using traditional matrices.

 

Tissue Analysis

For your tissue analysis, you need a partner that provides strong bioanalytical support. Our Bioanalytical Services Department has tenured experience and expertise in method development and processing of tissue for drug quantification. Our strength is the close partnership we forge with our clients, for the duration of a given project and beyond.

Once the processing method is established and ready for sample analysis, a special team is dedicated to tissue analysis. All work is conducted following a validation plan and/or a bioanalytical plan that is written by us and accepted by the sponsor. This plan is used if our standard procedure requires modifications to suit your needs, which is usually the case for tissue analysis.

 

New Chemical Entities (NCE)

Our method development team consists of experienced scientists dedicated to method development. Our extensive experience in the development of new chemical entities (NCE), bioanalytical methods and our state-of-the-art instrumentation have allowed us to achieve:

  • Extremely low LLOQ
  • Low sample volume
  • Large dynamic ranges
  • Quantification of multiple metabolites

One of our main focuses during method development is to have methods that are free of interference from metabolites. In collaboration with our sponsors, we perform thorough literature research and a review of the investigator brochure to determine the presence of potentially unstable metabolites. If no information on metabolites is available at the pre-clinical stage, investigation with the animal samples will be done to evaluate the presence of suspected metabolites. Our goal with this procedure is to ensure that our reported results are not biased by the presence of a metabolite. Also, in the correct circumstances, metabolite testing is performed using authentic reference standards.

Once a method is ready for validation and sample analysis, a special team is dedicated to the NCE work in order continue the relationship established during method development. All work is conducted toGLP standards and current regulatory guidelines. If required, our standards can be modified to suit your needs.

 

Compliance and Quality Compliance Group

A key priority is maintaining accuracy and quality throughout our clinical studies. On top of our stringent precision and process control guidelines, which ensure the high accuracy of results, our Compliance Team is imbedded in the Bioanalytical Services Department and maintains the following goals:

  • Uphold a close partnership and seamless consultation with clients
  • Stay up-to-date with current and upcoming regulations
  • Work closely with Bioanalysis and Method Development groups to quickly resolve OOS/Events
  • Implementation and management of CAPA programme

The Compliance Group focuses on quality improvement and efficiency, incorporating Internal audits to identify potential quality issues before they leave the department. There are also trending and metrics analyses performed on OOS data, deviations and audit citations which are presented monthly to departmental management.

Approvals, Certificates, Authorisations

  • GCP
  • GLP
  • GMP

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