Services
TGD offers a range of services to the pharmaceutical, biotechnology, and medical device companies. We make every necessary possible so that new products reach the market as soon as possible.
TGD is a research organization that is just the right size for most of your needs. Not too big and bureaucratic, but rather agile and flexible. Not too small, but with the demonstrated depth of experience and knowledge to bring real value to your project.
Regulatory Affairs
The regulation of clinical trials in Romania is being determined by EU directives. Regulatory acts are occasionally changing, therefore local expertise is essential. Our aim is to assist you with a broad range of regulatory affairs services that can help you shorten the approval process and therefore the trial duration. |
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- Advice on Romanian regulatory procedures (EC and NMA-MD)
- Preparation and submission of regulatory documents
- Obtain permission at the local and central levels to conduct clinical trial
- Preparation and submission of Marketing Authorization (MA) applications
- Import of drug
- Provision of official documents, specific procedures and translations
- Expert Reports
Site Selection and Project Management
Facilitating the negotiations between the hospital the investigator and the sponsor can be a key factor to the success of the trial. Our project management team provides the leadership to plan and integrate activities, keep projects on time and on budget while maintaining quality throughout the trial.
- Prepare clinical development plan
- Recruit investigators through our direct contact and in-house investigator database
- Train investigators and site personnel
- Study site support
- Patient recruitment and retention
- Randomization, repackaging, coding and labeling of investigational drugs
- Schedule monitoring activities
- Arrange and conduct steering committee meetings
- Provide clean and locked data
- Archiving
Medical Writing
Our medical writers have strong roots in academia and in the pharmaceutical and biotechnological industries; they can help you prepare clear, concise, and accurate documents:
- Investigator Brochure
- Protocol
- Case Report Form
- Patient information leaflets for clinical trials and package inserts
- Informed Consent Form
- Safety data reports
- Statistical analysis plan
- Medical translation services
- Regulatory submissions
- Final Report
Study Site Support
We provide a wide range of clinical research services at the study site to meet quality and ICH-GCP compliance at the highest level
- Site/Investigator identification and selection
- Site initiation
- Medical monitoring
- Study close-out
- Query Management
Safety Surveillance
Our clinical research team is available on 24/7 to address medically related questions or to report adverse events. Safety surveillance and reporting services include:
- Review of Protocol, Investigator Brochure, Informed Consent Form, and Case Report Form
- Safety monitoring
- Serious Adverse Event collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory authorities
- Un-blinding during Serious Adverse Event
- Developing safety database
- Periodic safety update reports
- Organize IDMB (Independent Data and Safety Monitoring Board)
- Pharmacovigilance local representation
- Receiving, processing, archiving adverse events/ reactions information
- Ensure compliance with local and international requirements
- Report to Health Authorities
- Pharmacovigilance consulting
- Preparation of written pharmacovigilance procedures (SOPs)
- Evaluation of pharmacovigilance systems performance
- Implementation of pharmacovigilance systems
- Preparation of PSUR (Periodic safety update reports)
- External pharmacovigilance courses
Clinical Compliance
Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements
- ICH-GCP compliance review
- IRB audits
- On-site investigator audits
- Drug accountability reviews
- Clinical compliance per protocol
Training Courses
Background
All too often, the only teaching of Good Clinical Practice (GCP) investigators receive consists of one or two hours’ refreshment course during an investigators’ meeting for a specific trial. Aware of the importance that all investigators and co-investigators who participate in trials are proficient in GCP, EMA strongly recommends that in-depth, stand-alone courses and respective certification are made available.
The program
Training courses represent cooperation between Tangent CME, a not-for-profit organization, and Craiova University of Medicine, aimed at providing high-quality GCP to investigators, study coordinators, and other participants in clinical trials. The project’s novelty is in its format and its curriculum comprehensiveness, all under the academic sponsorship of a medical school.
Section 1
A critical review of the trial concept
Section 2
Clinical trial design
Section 3
Ethical issues
Section 4
Study organization
Section 5
Legal, regulatory and good practice framework
Section 6
Study conduct
Section 7
Reporting clinical trials
Global Pharmacovigilance
TGD offers comprehensive global pharmacovigilance solutions for clinical safety.
TGD expertly develops a pharmacovigilance management plan that describes in detail the safety processes. The safety system is supported and administered by highly skilled TGD technical and medical affairs, EUDRA-vigilance trained staff.
TGD is focused on providing our clients with the full support and flexibility they need to meet their international obligations for adverse event reporting.
TGD's Pharmacovigilance Services include:
SAE/AE Handling
- Adverse event (AE) and serious adverse event (SAE) data entry and logging
- Current treatment utilization patterns
- Disease burden and prevalence
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Medical Analysis
- AE and SAE evaluations
- SAE narrative writing
- Physician medical review and signal detection
- Literature reviews and summaries
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Data Management
- AE and SAE logging, tracking, coding and case processing
- MedDRA and WHO-DD coding
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Regulatory Reporting
- Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports
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Patient Recruitment and Assesment
Drug Development in Mental Illnesses: The Issues
- Poor understanding of pathophysiology of mental illnesses
- There exist no validated targets in preclinical drug development stages
- Go/no-go decisions can only be made after the Proof Of Concept (POC) stage
- To end the POC stage a sponsor has to spend approximately $50 million
- About 9-10 compounds are abandoned at the POC stage because of unpredictable lack of efficacy or AE
- A few POC trials fail due to avoidable faults in clinical trial methodologies or execution
- Over the last 3 decades the number of PCO failed and false negative trials is increasing and the effect size between active drugs and placebo decreasing
- Increasing sample sizes and investigators number has proven an expensive and inefficient solution to the high failure rate
- Factors hypothesized to contribute to study failures are:
- Poor application of study eligibility criteria
- Large numbers of raters who achieve low intra-raters correlations
- High rate of placebo response
- Incentives for patients’ recruitment speed without incentive for quality
Proposed solutions
- Reducing the number of raters and improving rater’s training
- Monitoring raters performance and re-training during the trial
- Centralized, on-line assessment of eligibility and severity using remote video technologies
- Taping assessments for review by experts
- Separating rating and raters from the trial sites
TGD solution: Regional Expert Rating (RER)
- Core group of full-time raters with basic training in psychiatry or psychology
- Training in basic assessment instruments (SCID, PANSS, Ham-D, MATRICS, MADRAS, ADAS)
- Additional trail-specific training
- Raters, who are not part of the trial site, are assigned to sites based on geographical distribution
- Patients screened and found eligible by the PI are interviewed in person by the RER
- The same RER perform severity ratings throughout the trial duration
- Senior psychiatrist is available to the RER to review eligibility and baseline assessments.
- Unexpected or unexplainable scores such as abrupt improvements following baseline severity assessment will be adjudicated promptly and dealt with according to the SOP.
RER advantages
- Suitable for POC trials of small- to medium-size.
- Easy to implement
- Transparent to the sponsor and investigators
- Avoids difficulties which might emerge from patients’ and investigators’ concerns with unfamiliar technologies
- Cost effective
The above services are governed by TGD’s written Standard Operating Procedures and Technical Guidelines and comply with the ICH Guidelines on Good Clinical Practice (GCP).
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