OUR SERVICES

Our customized clinical data management services, including EDC, Clinical Data Review, Coding, CDISC Conversation & Data Standardization enables complete utilization of the collected clinical data.

The complementary biostatistical services, including SAP Development, SAS Clinical Programming, Analysis, Submission-Ready Services and Statistical Reports are customized and designed specifically to meet the project requirements

Clinical Data Management

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture – Medidata’s Clinical Cloud.

 

We manage all aspects of your data – from study startup to submission, and closely collaborate with clinical teams ensuring they meet the timelines and milestones of their trial.

 

Bioforum is a data-focused CRO, therefore we strongly standby the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

 

Bioforum’s Clinical Data Management Support Services:

  • Data Management Plan Development
  • Clinical Data Review and Query Management
  • External Data Transfer and Reconciliation
  • Adverse Event, Concomitant Medication, and Medical History Coding
  • SAE Reconciliation between Safety and Clinical Databases
  • Development of Custom Status Reports
  • Database Lock Procedures

Electronic Data Capture

We are here every step of the way to get our clients clinical trials submission-ready.  By combining our clinical expertise and data management analysis we enhance the design implementation and use of Electronic Data Capture (EDC). We face challenges and complexities of collecting patient data while implementing data standards and ensuring reusability for subsequent studies.

Our Services Include:

  • eCRF Design
  • Database design and validation
  • Edit check programming and testing

The Technology

Bioforum is a certified Medidata Services Partner. We implement and leverage the industry-leading EDC platform (Rave) to support the growing needs of trial managers and study teams. Medidata fully optimizes the data capture process and increases site satisfaction and efficiency by eliminating redundant systems and processes, which decreases trial risks and improves the quality of your trial’s data.

Key Benefits:

  • The industry’s gold standard for EDC (95% of pharma companies run their clinical trials on Rave)
  • Compliant with global regulatory requirements, including 21 CFR Part 11 e-signatures
  • Configurable workflows and security permissions for data entry, review and approval
  • Easily manage mid-study changes

Biostatistics

Advanced Biostatistics for More Efficient Clinical Trials

Today, a small portion of new compounds succeed to reach the market. There is an increasing need for advanced biostatistics and efficient clinical development strategies to shorten timelines, reduce costs and risks, and improve the quality of submissions. High level advanced statistical methods play a key role in every step of the drug development process.

In Bioforum we believe that the most efficient and cost-effective way to conduct and control clinical trials is to make the best possible use of advanced and innovative statistical methodology.

Various Services in Advanced Biostatistics

  • Study Design
  • Choice of endpoints
  • Statistical Analysis Plan
  • Sample size calculation
  • Trial simulations
  • Statistical Analysis
  • Comprehensive Data Monitoring Committee Services
  • Meta-analysis
  • Representation at meetings with the Regulatory Authorities
  • Integrated summaries of safety and of efficacy
    (ISS,  ISE or PASS, PAES) and statistical sections of NDAs/EU submissions

In working with sponsors:

  • We give special attention to the objectives of the protocol in order to fit the right statistical methodology.
  • We communicate with clinicians to determine the possible outcomes and make sure we optimize your clinical trial by developing the right study design with optimal size and length.
  • We assess the inherent risk in the study design and ensure robustness and consistency of clinical trial results.
  • Help make better data-driven decisions, mitigate risks, and improve the quality and success probability for study submissions by employing advanced methodologies (e.g., Bayesian methods, modelling and simulations, biomarkers validation etc.
  • We ensure high quality throughout all stages of drug development thanks to our experience and profound understanding of ICH GCP, regulatory requirements and ADaM analysis datasets

Our expert biostatisticians offer flexible and innovative solutions for clinical research, and are not afraid to challenge the status quo. With strong science background and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial.

1. Study Design

Well-designed clinical trials are essential to a successful clinical development. Many compounds do not get into the market because of flaws in the design stage. To optimize your study, you need a partner who will carefully help you plan the course of your clinical trial, proactively improve predictability, reduce risks, and help you reach Go/No-Go decisions faster. Bioforum biostatistician will partner with you to provide the optimal clinical trial design, looking for efficacy signals and achieve better outcomes for the resources spent. This includes developing the synopsis and the full protocol document, calculating the sample size for conventional, group-sequential or adaptive designs (including Bayesian designs), running trial simulations, and proposing innovative solutions to expedite and optimize chances of success of your clinical trial.

Clinical Trial Design Services Include:

    • Selection of the patient population;
    • Randomization
    • Choice of efficient and reliable endpoints, as well as validation of surrogate endpoints;
    • Sample size calculation;
    • Sample size re-assessment during the study (blinded or unblinded using DMC)
    • Trial simulations;
    • Adaptive trial set-up;
    • Factorial and cross-over designs for selected situations;
    • Statistical analysis using of state-of-the art and novel methods;
    • Interim analysis
    • Experience in assisting clients in dealing with regulatory authorities, including the FDA and EMA, to discuss the study design or to defend the study results.

2. Randomization

Biostatistics-Driven IRT/IWRS: Unbiased Assessment of Outcomes in Clinical Trials

We will provide the most appropriate randomization methodology to meet your trial’s specific needs – this could be  dynamic randomization (minimization), preplanned schedule (balanced or unbalanced), stratified randomization according to prognostic factors, multi-stage or any other method to help customize your study goals. The IRT/IWRS is fully integrated with our EDC system, and is adjustable throughout the clinical trial with no downtime.

3. Comprehensive Data Monitoring Committee Services

A DMC – Data Monitoring committee or DSMB – Data Safety Monitoring Board, is an independent panel of experts who periodically review clinical trial data to ensure integrity, scientific rigor and patient safety in clinical studies. To support this critical function, Bioforum provides comprehensive Data Monitoring Committee services designed for pharmaceutical and biotech companies.

  • Data Monitoring Committee Expertise:
    • Independent statistician
    • Charter design or review
    • Safety and interim efficacy analyses:
    • Design of templates
    • Data transfer from all parties: Sponsor, CROs, central laboratory, etc
    • Data quality review
    • Blinded or unblinded analyses
    • Tables, figures and listings for interim analyses
    • Writing of blinded/unblinded reports
  • Secure Data Sharing:
    • A secure data sync and sharing service with flexible storage options and access rights
    • Encrypts data over the web integrating stringent security requirements

Clinical Programming

As the largest group within Bioforum and a CDISC Registered Solution Provider since 2009, we provide diversified SAS programming services tailored to customer needs. Our clinical programmers have vast experience with many therapeutic areas and indication across different study phases and constantly keep up with current guidance and developments as they pertain to data standards and regulatory demands.

Services

  • CDISC – SDTM, ADaM, SEND (pre-clinical), SDTM-MD (Medical Devices)
  • Metadata – define.xml, SDRG and ADRG
  • Legacy studies support –
    • Gap analysis according to the latest regulation
    • Prepare legacy package for submission
    • Data conversion to CDISC standards
  • Statistical analysis of clinical data
    • As part of INDs, IDEs, NDAs, 510Ks, PMAs, ANDAs and BLAs
    • Study Interim analysis
    • Custom analysis per customer/regulatory agencies requirements
    • Meta-analyses of multiple sources
  • Tables, listings and figures (TLFs)
  • Data integration and analysis for safety and efficacy summaries (e.g., ISS/ISE)
  • Periodical and safety committees reports (e.g. DSUR, DMC)

Medical Writing

The core services of the Bioforum Medical Writing department will be those that are immediately linked to the planning, conduct, and reporting of clinical studies.

Additional services will be those that are part of the global product development program.

Core Services: Clinical Studies

  • Participation in study planning meetings
  • Review of study synopses and schedules of events
  • Writing protocols
    • Literature reviews for Introduction sections
    • Coordinating writing by other functions within Bioforum, including statistics and informed consent forms
    • Full internal review by statistics
    • Full review by data programming as part of preparation for CRF writing
    • Full QC
    • Protocol publishing services (rendering to PDF, hyper linking)
  • Review of statistical analysis plans, including table shells
  • Review of planned CRFs
  • Posting protocols to clinicaltrials.org
  • Writing protocol amendments and amended protocols
    • Full QC of each version
    • Protocol publishing services (rendering to PDF, hyper linking)
    • Tracking and recording protocol versions and changes between versions
  • Review of the Statistical Report
  • Writing Clinical Study Reports
    • Literature reviews for Introduction sections
    • Coordinating writing by other functions within Bioforum, including statistics
    • Full internal review by statistics
    • Full QC
      • QC of number and cross-reference accuracy against source TFLs
      • QC for English grammar and style, document format etc.
    • Writing/review of patient narratives
    • Report publishing services (rendering to PDF, hyper linking
  • Posting results to clinicaltrials.org
  • Writing journal articles
    • Conduct meetings to set a publication strategy
    • Convert CSR into an article/ multiple articles, as appropriate
    • Full internal review by statistics
    • Submission-ready files including figures
  • Writing/review of text for slide-decks for conference presentations
  • Writing/review of text for conference posters

Other Services: Support of Full Product Development Programs

  • Writing pediatric Investigational Plans and conversion to PDPs.
    • Participating in strategy meetings
    • Review of planned analyses and table shells
    • Conducting literature searches and writing background summaries
  • Writing briefing packages/books for meetings with regulators
  • Writing/updating Data safety update reports
    • Review of planned analyses and table shells
  • Writing/updating investigational brochures
  • Writing ISS/ISE SCS/SCE and clinical overview documents.
    • Fully integrated work with the statistics department
    • Participating in strategy meetings
    • Review of planned analyses and table shells
    • Writing/review of patient narratives
    • Writing the documents, full QC of all work products
    • Submission document publishing services

 

eCTD Regulatory Submissions

Our team is well-versed with the ICH Common Technical Document (CTD) specifications for marketing authorization in all therapeutic areas and indications.

We prepare, publish and compile eCTD submissions for the following:

  • Abbreviated new drug applications (ANDA)
  • Biologics license applications (BLA)
  • Clinical trial authorization/application/exemptions (CTA/CTX)
  • Clinical trial notifications (CTN)
  • Drug master files (DMF)
  • Fast track applications
  • Investigational device exemptions (IDE)
  • Investigational new drug applications (IND)
  • Investigational Medicinal Product Dossier application (IMPD)
  • Marketing authorization applications (MAA)
  • New drug applications (NDA)
  • New drug submissions (NDS)
  • Orphan drug applications (ODA)
  • Life Cycle Management and maintenance

According to these submissions, our services are tailor-made to your needs.

Pharmacovigilance

Pharmacovigilance –  also known as drug safety – describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies, and is an essential function within a life science company.

The  International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has significant guidelines for companies conducting clinical trials. Organizations are obligated to set up the right systems and processes to identify, record, report and analyze safety signals that could arise during a trial.

Bioforum provides all the  pharmacovigilance services required for your clinical trial.

 

Services Include:

  • Setup Activities
    • EudraVigilance Registration and Responsible Person (in case there are sites in the EU)
    • Test & submit electronic SUSAR to EMA (in case there are sites in the EU)
    • Safety Management Plan
    • Database setup
    • Legacy case entry
  • Adverse Drug Reaction Case Activities
    • Case entry and QC
    • Case assessment, narrative writing, and causality/expectedness assessment
    • Generate CIOMS/MedWatch
    • MedDRA Coding
    • Prepare electronic SUSAR
    • Distribute paper SUSAR to sites (in case customer wishes to)
  • Line listings
  • Authoring of the DSUR (Development Safety Update Report)
  • Strategic pharmacovigilance regulatory consultation

 

Our Database

We use PV-Works® as our Pharmacovigilance database – a cloud-based, FDA 21 CFR Part 11 compliant PV solution, that is used by various drug companies, CROs, and consultancies.

 

Pharmacovigilance Workflow Summarized

Pharmacovigilance process at Bioforum –

 

 

Pharmacovigilance process at Bioforum

  1. Study Setup I 
    • Safety Management Plan (SMP)
      Safety Management Plan (SMP) is prepared to fully detail the processes and procedures required as part of handling the Adverse Drug Reactions (ADRs) as part of the study conduct. All procedures and responsibilities are outlined and the plan is approved by the customer.
    • Database Setup
      Study is set up using PV-Works® in order to have all study cases processed, and all study information is configured in the database.
  2. Study Setup II – EudraVigilance Registration
    • If the study is planned to run within the European Union, we compile the documentation and register the trial Sponsor and EV Responsible Person in EudraVigilance.
  3. Case Reporting
    • The Investigator reports any Serious Adverse Event (SAE), whether it is considered to be related to study medication or not, by completing a Serious Adverse Event Form and sending it to the designated address (Within 24 hours).
  4. SUSAR Assessment
    • The SAE is then assessed by Bioforum PV personnel, determining whether the Adverse Event is serious and unexpected, which will qualify the event as a SUSAR and if so, whether a 7-day or a 15-day is required.
  5. Case Entry
    • The SAE is then entered into PV-Works® and 100% QC check is performed on the data entered. Often there is essential missing information for the case entry process, in which Bioforum can directly communicate with the site to quickly obtain the missing information.
  6. Medical Assessment
    • The designated Bioforum PV physician then codes the verbatim event term, medical history and other relevant information using MedDRA (the latest version of MedDRA), and perform case level assessment, write the clinical narrative for the case and communicate with the site at any data queries. All corresponded information is then appended to the case within PV-Works.
  7. SUSAR 7-days/15 days Reporting
    • A draft MedWatch 3500A or a CIOMS report is then produced and circled among the stakeholders. Changes are made to the case based on feedback still as a draft report. For cases that are not considered to be a SUSAR, this report will be used for information purposes only. For cases that are considered SUSARs, a submission-ready copy is then produced according to the agreed-upon timelines.
    • A 7-days or 15-days expedited report should be received by the ECs/IRBs (Ethical Committees/Institutional Review Boards) and RAs (Regulatory Agencies) no later than 7 or 15 calendar days, respectively after the sponsor or its representatives become aware of the event.
  8. Case Follow-up
    • Responses from the sites to any pharmacovigilance queries are added to the database following the process described above. All updates/changes are done using audit trail and do not compromise the original information that was entered.
    • If required, Bioforum discuss the case with the sponsor to decide whether as a result of the event, any action is necessary to protect patient safety and if so initiate such actions.
  1. Periodic Reporting
    • All SAEs that are reported are included in line listings, produced from the PV-Works database at time intervals requested by the customer. These listings are also incorporated into the Development Safety Update Report (DSUR) using the requirements and structure defined in the ICH guideline E2F.